510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904536Substantially Equivalent

Jain Graft Assist

Jain Surgical Equipment, Inc., Kalamazoo MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904536 is the FDA 510(k) clearance record for JAIN GRAFT ASSIST, a class I device, cleared for Jain Surgical Equipment, Inc. on under FDA product code GCZ (Retainer, Surgical). FDA records list 5 510(k) clearances for Jain Surgical Equipment, Inc., from to . As of , FDA records show no recalls naming K904536.

Clearance record

Decision date
Received
(56 days to decision)
Product code
GCZ Retainer, Surgical
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Jain Surgical Equipment, Inc. 7829 Sprinkle Rd., Kalamazoo MI
Third party review
No

Clearances, product code GCZ

Trailing 12 months

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

FDA records show no clearances under product code GCZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GCZ, 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