510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K080898Substantially Equivalent

Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line Reinforcement

Tyco Healthcare Group LP, North Haven CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080898 is the FDA 510(k) clearance record for AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT, a class II device, cleared for Tyco Healthcare Group LP on under FDA product code GDW (Staple, Implantable). FDA records list 6 510(k) clearances for Tyco Healthcare Group LP, from to . As of , FDA records show 24 recalls naming K080898.

Clearance record

Decision date
Received
(35 days to decision)
Product code
GDW Staple, Implantable
Regulation
21 CFR 878.4750
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Tyco Healthcare Group LP 60 Middletown Ave., North Haven CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GDW

Trailing 12 months
4 clearances under product code GDW in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GDW, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260