510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K040472Substantially Equivalent

Force Fiber Blue Co-Braided Polyethylene Nonabsorbable Surgical Suture

Teleflex Medical, Durham NC / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040472 is the FDA 510(k) clearance record for FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE, a class II device, cleared for Teleflex Medical on under FDA product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). FDA records list 80 510(k) clearances for Teleflex Medical, from to . As of , FDA records show no recalls naming K040472.

Clearance record

Decision date
Received
(20 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
Teleflex Medical 2917 Weck Dr., Durham NC
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 November 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GAT, trailing twelve months
MonthClearances
December 20250
January 20260
February 20261
March 20261
April 20260
May 20261
June 20260
July 20261
August 20261
September 20260
October 20260
November 20260