510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001434Substantially Equivalent for Some Indications

'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture

Genzyme Surgical Product (Genzyme Biosurgery), Fall River MA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K001434 is the FDA 510(k) clearance record for 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE, a class II device, cleared for Genzyme Surgical Product (Genzyme Biosurgery) on under FDA product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). FDA records list 9 510(k) clearances for Genzyme Surgical Product (Genzyme Biosurgery), from to . As of , FDA records show one recall naming K001434.

Clearance record

Decision date
Received
(35 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 Surgical Product (Genzyme Biosurgery) 600 Airport Rd., Fall River MA
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