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
K050771Substantially Equivalent

Lupine Loop

DePuy Mitek, Inc., Norwood MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050771 is the FDA 510(k) clearance record for LUPINE LOOP, a class II device, cleared for Depuy Mitek, A Johnson & Johnson Company on under FDA product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). FDA records list 80 510(k) clearances for DePuy Mitek, Inc., from to . As of , FDA records show no recalls naming K050771.

Clearance record

Decision date
Received
(14 days to decision)
Product code
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Regulation
21 CFR 878.4493
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Depuy Mitek, A Johnson & Johnson Company 249 Vanderbilt Ave., Norwood MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAM

Trailing 12 months
6 clearances under product code GAM in the twelve months to November 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GAM, trailing twelve months
MonthClearances
December 20252
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260
November 20260