510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K862597Substantially Equivalent

Various Surgical Instruments

Konig W.G., Ltd., Williamsville NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862597 is the FDA 510(k) clearance record for VARIOUS SURGICAL INSTRUMENTS, a class I device, cleared for Konig W.G., Ltd. on under FDA product code GAD (Retractor). FDA records list one 510(k) clearance for Konig W.G., Ltd. As of , FDA records show no recalls naming K862597.

Clearance record

Decision date
Received
(21 days to decision)
Product code
GAD Retractor
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Konig W.G., Ltd. P.O. Box 443, Williamsville NY
Third party review
No

Clearances, product code GAD

Trailing 12 months

FDA records hold no clearances under product code GAD in the trailing twelve months.

FDA records show no clearances under product code GAD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GAD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260