EMC FLEXIBLE BIOPSY FORCEPS— 510(k) K941816

Name: FDA 510(k) clearance K941816
Creator: U.S. Food and Drug Administration
Published: 1994-07-13

Substantially Equivalent

Enterprise Medical Corp.

FDA 510(k) clearance K941816 for EMC FLEXIBLE BIOPSY FORCEPS, Substantially Equivalent on 1994-07-13. Applicant: Enterprise Medical Corp.. Device class: 1.

Clearance details

Applicant: Enterprise Medical Corp.
Product code: Code FCL
Device class: Class 1
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1994-04-13
Decision date: 1994-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greensboro, NC, US

Download summary PDF View on FDA.gov ↗

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K964120 — INJECTO FLUSH1996-12-30
K963517 — SPECTRA SCIENCE BIOPSY FORCEPS1996-12-02

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K942431 — LAPOROSCOPIC SCISSORS1995-10-11
K943583 — KERRISON RONGEURS1995-02-21

Adverse events under product code FCL

product code FCL

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.