510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900065Substantially Equivalent

Non-Electric Biopsy Forceps

Esco Precision, Inc., Stony Brook NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900065 is the FDA 510(k) clearance record for NON-ELECTRIC BIOPSY FORCEPS, a class I device, cleared for Esco Precision, Inc. on under FDA product code FCL (Forceps, Biopsy, Non-Electric). FDA records list 3 510(k) clearances for Esco Precision, Inc., from to . As of , FDA records show no recalls naming K900065.

Clearance record

Decision date
Received
(70 days to decision)
Product code
FCL Forceps, Biopsy, Non-Electric
Regulation
21 CFR 876.1075
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Esco Precision, Inc. 21 William Penn Dr., Stony Brook NY
Third party review
No

Clearances, product code FCL

Trailing 12 months

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

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