510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K931271Substantially Equivalent

Ethi-Pack* Surgical Stainless Steel Suture

Ethicon, Inc, Somerville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931271 is the FDA 510(k) clearance record for ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE, a class II device, cleared for ETHICON, Inc. on under FDA product code GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile). FDA records list 208 510(k) clearances for ETHICON, Inc., from to . As of , FDA records show no recalls naming K931271.

Clearance record

Decision date
Received
(305 days to decision)
Product code
GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Regulation
21 CFR 878.4495
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
ETHICON, Inc. Rte. 22 W. P.O. Box 151, Somerville NJ
510(k) summary
Summary
Third party review
No

Clearances, product code GAQ

Trailing 12 months

FDA records hold no clearances under product code GAQ in the trailing twelve months.

FDA records show no clearances under product code GAQ in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GAQ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260