510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K061796Substantially Equivalent

Hepatostat Set, Model 760X

Vygon Corp., Farmington Hills MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061796 is the FDA 510(k) clearance record for HEPATOSTAT SET, MODEL 760X, a class II device, cleared for Vygon Corp. on under FDA product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). FDA records list one 510(k) clearance for Vygon Corp. As of , FDA records show no recalls naming K061796.

Clearance record

Decision date
Received
(129 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
Vygon Corp. 30833 Northwesters Hwy., Farmington Hills MI
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 October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GAM, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260