Surgeon Experience

FDA 510(k) Acceptance Notice for V-CLAMP

The U.S. FDA has accepted the V-CLAMP premarket notification, advancing regulatory review for North American commercialization.

2026.02 Regulatory Affairs, Hongyu Medical

FDA 510(k) Acceptance Notice for V-CLAMP

Hongyu Medical announced FDA acceptance of the 510(k) submission for V-CLAMP, covering laparoscopic vascular closure indications in companion animals.

Submission Scope

The dossier includes bench biocompatibility, animal safety studies, and clinical performance summaries from international sites.

Next Steps

The review timeline will determine U.S. market entry sequencing alongside existing CE-marked territories.

FDA 510(k) Acceptance Notice for V-CLAMP

Submission Scope

Next Steps

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