510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032160Substantially Equivalent

Artelon Surgical Suture

Artimplant AB, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032160 is the FDA 510(k) clearance record for ARTELON SURGICAL SUTURE, a class II device, cleared for Artimplant AB on under FDA product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide). FDA records list 7 510(k) clearances for Artimplant AB, from to . As of , FDA records show no recalls naming K032160.

Clearance record

Decision date
Received
(125 days to decision)
Product code
GAR Suture, Nonabsorbable, Synthetic, Polyamide
Regulation
21 CFR 878.5020
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Artimplant AB 719 A St. NE, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAR

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