510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K965162Substantially Equivalent

Lukens Pga, (Polyglycolic Acid) Synthetic Absorbable Surgical Suture,coated, Braided-U.s.p.

Lukens Medical Corp., Mahwah NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K965162 is the FDA 510(k) clearance record for LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P., a class II device, cleared for Lukens Medical Corp. on under FDA product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). FDA records list 8 510(k) clearances for Lukens Medical Corp., from to . As of , FDA records show one recall naming K965162.

Clearance record

Decision date
Received
(50 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
Lukens Medical Corp. The Lahr Consulting Group,Inc., Mahwah NJ
510(k) summary
Summary
Third party review
No

Clearances, product code GAM

Trailing 12 months
5 clearances under product code GAM in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GAM, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260