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Novafil Suture, Nonabsorbable, Synthetic, Polyester

by Davis & Geck, Inc. PMA

Active United States

PMA P840041

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP840041 Date8 Aug 1989ApprovedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

PMA

Full name
Novafil(Tm)
Generic Name
Suture, nonabsorbable, synthetic, polyester
PMA Number
FDA Product Code
GAS
Device Class
Class II
Regulation
21 CFR Part 878.5000
Advisory Committee
General, Plastic Surgery
FDA Decision
APPR Approved
PMA Supplement
S004 (Normal 180 Day Track)

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.

The Novafil Suture is a nonabsorbable, synthetic, polyester suture designed for general and plastic surgery applications. It is classified as a Class II medical device and is intended for use in tissue approximation and ligation during surgical procedures.

This suture is supplied in sterile, single-use packaging and is regulated under FDA Premarket Approval (PMA) with the designation P840041. It is manufactured by Davis & Geck, Inc., and adheres to regulatory standards outlined in 21 CFR 878.5000. Multiple product codes and registration numbers are associated with its distribution, ensuring compliance with U.S. medical device regulations.

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