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Surgidek

by Sutures, Ltd.

510(k) K943216

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK943216 Date5 Dec 1994DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GAR
FDA applicant
Sutures , Ltd.
Device Class
Class II
Regulation
21 CFR Part 878.5020
Advisory Committee
General, Plastic Surgery
FDA Decision
SN

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Surgidek is a nonabsorbable, synthetic, polyamide suture. It is intended for use in general and plastic surgery procedures.

This device is regulated under FDA 510(k) clearance K943216. It is manufactured by Sutures, Ltd. and is classified as a class 2 medical device.

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