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
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K042141Substantially Equivalent

Polyglytone 6211 Synthetic Absorbable Suture

Teleflex Medical, Fall River MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042141 is the FDA 510(k) clearance record for POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE, a class II device, cleared for Teleflex Medical on under FDA product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). FDA records list 80 510(k) clearances for Teleflex Medical, from to . As of , FDA records show no recalls naming K042141.

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
Teleflex Medical 600 Airport Rd., Fall River 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