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Absorbable Surgical Suture, USP

by Ethicon Inc. 3 variants

PMA N10389

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA N10389

FDA record

Trust

Unverified

Source FDA PMA, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberN10389 Date4 Apr 1983ApprovedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Generic name
Suture, absorbable, natural
FDA applicant
ETHICON, Inc.
PMA number
FDA product code
GAL
Device class
Class II
Regulation
21 CFR Part 878.4830
Advisory committee
General, Plastic Surgery
FDA decision
APPR Approved
PMA supplement
S018

Overview

AI-generated summary, 18 Sep 2026

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

This device is an absorbable suture classified as a natural, resorbable monofilament or multifilament thread used for internal and external wound closure. It is designed to gradually dissolve and be absorbed by the body after serving its purpose, reducing the need for suture removal.

The suture is supplied in sterile, single-use packaging and is intended for use in general and plastic surgery procedures. It is regulated under FDA Premarket Approval (PMA) and falls under device classification GAL (General and Plastic Surgery). Available in various sizes and configurations, it must be stored according to manufacturer instructions to maintain sterility and integrity.

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