Dyne Medical Group’s Endoscopic Connector ‘DYNE PORT’ Receives U.S. FDA 510(k) Clearance
Following URUS, the company secures U.S. regulatory approval for another key urology product, strengthening its global competitiveness.
SEOUL, South Korea, June 19, 2026 —
Dyne Medical Group Inc. (CEO Sung Hoon Lee) announced that its endoscopic connector device, Port-C (U.S. product name: DYNE PORT), has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
(From left) Dyne Medical Group’s flexible ureteroscope URUS connected with Port-C (DYNE PORT), and a standalone image of Port-C.
Photo courtesy of Dyne Medical Group Inc.
This FDA clearance is particularly meaningful as it follows the company's previous FDA approval for URUS, Korea’s first domestically developed single-use flexible ureteroscope. With the approval of DYNE PORT, Dyne Medical Group has now secured U.S. market entry authorization not only for its endoscopic platform but also for a key procedural accessory used during endourological procedures.
As a result, the company has further strengthened its position as a global urology device manufacturer by establishing a comprehensive product portfolio covering both endoscopic systems and procedural accessories.
DYNE PORT is an endoscopic connector used during Retrograde Intrarenal Surgery (RIRS) for the treatment of kidney and ureteral stones. The device is attached to a ureteroscope and assists in the manipulation of treatment instruments such as laser fibers and stone retrieval baskets. It was developed to address limitations associated with conventional Y-connector systems.
Traditional Y-connectors typically require repeated opening and closing of the instrument port whenever device positioning is adjusted, which can reduce procedural efficiency and create inconvenience for clinicians. In contrast, DYNE PORT allows users to lock or finely adjust treatment instruments through a simple lever mechanism, enabling more intuitive and precise control.
The device also allows physicians to perform fine instrument adjustments with one hand while maintaining visual focus on the surgical monitor, improving both procedural convenience and accuracy. In addition, it can reduce dependence on assisting personnel and help minimize fluid leakage or splashing that may occur during instrument exchanges, contributing to a safer procedural environment.
Since its domestic launch last year, DYNE PORT has received positive feedback from clinicians for its user-friendly design and differentiated mechanism. In March 2026, the product also entered the Japanese market through an official distribution agreement with Medical Leaders Co., Ltd.
With FDA clearance now secured for both URUS and DYNE PORT, Dyne Medical Group has further strengthened its presence in the field of endourology by offering a complete portfolio encompassing both endoscopic visualization systems and procedural accessories.
“Receiving FDA clearance for DYNE PORT is significant because it validates both the safety and technological innovation of our product on a global level,” said Sung Hoon Lee, CEO of Dyne Medical Group Inc. “We will continue developing innovative medical devices that address real-world clinical challenges and improve the procedural experience for healthcare professionals.”
Dyne Medical Group continues to expand its business through a diverse portfolio of urology products, including URUS, DYNE PORT, and ClearPetra, while actively pursuing global partnerships and distribution networks to strengthen its presence in international markets.
Dyne Medical Group’s Endoscopic Connector ‘DYNE PORT’ Receives U.S. FDA 510(k) Clearance
Following URUS, the company secures U.S. regulatory approval for another key urology product, strengthening its global competitiveness.
SEOUL, South Korea, June 19, 2026 —
Dyne Medical Group Inc. (CEO Sung Hoon Lee) announced that its endoscopic connector device, Port-C (U.S. product name: DYNE PORT), has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
(From left) Dyne Medical Group’s flexible ureteroscope URUS connected with Port-C (DYNE PORT), and a standalone image of Port-C.
Photo courtesy of Dyne Medical Group Inc.
This FDA clearance is particularly meaningful as it follows the company's previous FDA approval for URUS, Korea’s first domestically developed single-use flexible ureteroscope. With the approval of DYNE PORT, Dyne Medical Group has now secured U.S. market entry authorization not only for its endoscopic platform but also for a key procedural accessory used during endourological procedures.
As a result, the company has further strengthened its position as a global urology device manufacturer by establishing a comprehensive product portfolio covering both endoscopic systems and procedural accessories.
DYNE PORT is an endoscopic connector used during Retrograde Intrarenal Surgery (RIRS) for the treatment of kidney and ureteral stones. The device is attached to a ureteroscope and assists in the manipulation of treatment instruments such as laser fibers and stone retrieval baskets. It was developed to address limitations associated with conventional Y-connector systems.
Traditional Y-connectors typically require repeated opening and closing of the instrument port whenever device positioning is adjusted, which can reduce procedural efficiency and create inconvenience for clinicians. In contrast, DYNE PORT allows users to lock or finely adjust treatment instruments through a simple lever mechanism, enabling more intuitive and precise control.
The device also allows physicians to perform fine instrument adjustments with one hand while maintaining visual focus on the surgical monitor, improving both procedural convenience and accuracy. In addition, it can reduce dependence on assisting personnel and help minimize fluid leakage or splashing that may occur during instrument exchanges, contributing to a safer procedural environment.
Since its domestic launch last year, DYNE PORT has received positive feedback from clinicians for its user-friendly design and differentiated mechanism. In March 2026, the product also entered the Japanese market through an official distribution agreement with Medical Leaders Co., Ltd.
With FDA clearance now secured for both URUS and DYNE PORT, Dyne Medical Group has further strengthened its presence in the field of endourology by offering a complete portfolio encompassing both endoscopic visualization systems and procedural accessories.
“Receiving FDA clearance for DYNE PORT is significant because it validates both the safety and technological innovation of our product on a global level,” said Sung Hoon Lee, CEO of Dyne Medical Group Inc. “We will continue developing innovative medical devices that address real-world clinical challenges and improve the procedural experience for healthcare professionals.”
Dyne Medical Group continues to expand its business through a diverse portfolio of urology products, including URUS, DYNE PORT, and ClearPetra, while actively pursuing global partnerships and distribution networks to strengthen its presence in international markets.