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Polyviolene Suture

by Look, Inc. 510(k)

Active United States

510(k) K904054

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK904054 Date3 Oct 1990ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Polyviolene(Tm) Suture
510(k) Number
FDA Product Code
GAS
Device Class
Class II
Regulation
21 CFR Part 878.5000
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

Polyviolene Suture is a nonabsorbable, synthetic, polyester surgical suture. It is designed for use in general and plastic surgery procedures.

This device is regulated as a Class 2 medical device under regulation number 878.5000. It has received FDA 510(k) clearance.

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