510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853104Substantially Equivalent

Disposable, Sterile Biopsy Punch

August C. Stiefel Research Institute, Inc., Oakhill NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853104 is the FDA 510(k) clearance record for DISPOSABLE, STERILE BIOPSY PUNCH, a class II device, cleared for August C. Stiefel Research Institute, Inc. on under FDA product code FCI (Punch, Biopsy). FDA records list one 510(k) clearance for August C. Stiefel Research Institute, Inc. As of , FDA records show no recalls naming K853104.

Clearance record

Decision date
Received
(73 days to decision)
Product code
FCI Punch, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
August C. Stiefel Research Institute, Inc.
Third party review
No

Clearances, product code FCI

Trailing 12 months

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

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