FDA applicant

Coviden (Formerly Registered AS US Surgical, A Div

North Haven, CT1 decision2011–20110 recalls

FDA records 1 decision for Coviden (Formerly Registered AS US Surgical, A Div (North Haven, CT) in 2011: 1 510(k) clearance. All are in product code GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Coviden (Formerly Registered AS US Surgical, A Div’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Coviden (Formerly Registered AS US Surgical, A Div by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Coviden (Formerly Registered AS US…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Coviden”

FDA records each applicant name separately; these may or may not be the same firm.

Coviden, LLC 1

Coviden (Formerly Registered AS US Surgical, A Div

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Coviden”