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Absorbable Surgical Suture, USP

by Ethicon Inc. 3 variants

PMA N14226

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 N14226

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 NumberN14226 Date20 Jun 1986ApprovedStatusActive

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  • Withdrawn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
S006

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 made from natural materials, designed for internal tissue approximation and wound closure. Absorbable sutures dissolve over time within the body, eliminating the need for suture removal, and are classified as a Class II medical device under FDA regulations.

The suture is supplied in sterile form for single-use in surgical settings, including general and plastic surgery procedures. It is intended for internal use only and must be handled under aseptic conditions. No specific MRI safety information is provided, and sizes or packaging details are not detailed in the submitted data. The device holds an FDA Premarket Approval (PMA) under PMA number N14226.

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