510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941816Substantially Equivalent

Emc Flexible Biopsy Forceps

Enterprise Medical Corp., Greensboro NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941816 is the FDA 510(k) clearance record for EMC FLEXIBLE BIOPSY FORCEPS, a class I device, cleared for Enterprise Medical Corp. on under FDA product code FCL (Forceps, Biopsy, Non-Electric). FDA records list 3 510(k) clearances for Enterprise Medical Corp., from to . As of , FDA records show no recalls naming K941816.

Clearance record

Decision date
Received
(91 days to decision)
Product code
FCL Forceps, Biopsy, Non-Electric
Regulation
21 CFR 876.1075
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Enterprise Medical Corp. 3214 Brassfield Rd., #2201, Greensboro NC
510(k) summary
Statement
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