510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021019Substantially Equivalent

Cottony II, Silky II Polydek & Tevdek II Polyester Suture

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

K021019 is the FDA 510(k) clearance record for COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE, a class II device, cleared for Genzyme Corp. on under FDA product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). FDA records list 33 510(k) clearances for Genzyme Corp., from to . As of , FDA records show 7 recalls naming K021019.

Clearance record

Decision date
Received
(81 days to decision)
Product code
GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Regulation
21 CFR 878.5000
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Genzyme Corp. 600 Airport Rd., Fall River MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAT

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