510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K133356Substantially Equivalent

Prolene Polypropylene Nonabsorbable Suture

Ethicon, Inc, Somerville NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133356 is the FDA 510(k) clearance record for PROLENE POLYPROPYLENE NONABSORBABLE SUTURE, a class II device, cleared for ETHICON, Inc. on under FDA product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene). FDA records list 208 510(k) clearances for ETHICON, Inc., from to . As of , FDA records show 21 recalls naming K133356.

Clearance record

Decision date
Received
(36 days to decision)
Product code
GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Regulation
21 CFR 878.5010
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
ETHICON, Inc. Rte. 22 W., Somerville NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAW

Trailing 12 months
1 clearance under product code GAW in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GAW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260