FORCEPS, BIOPSY, GASTROINTESTINAL— 510(k) K934186

Name: FDA 510(k) clearance K934186
Creator: U.S. Food and Drug Administration
Published: 1993-12-14

Substantially Equivalent

Primed Instruments, Inc.

FDA 510(k) clearance K934186 for FORCEPS, BIOPSY, GASTROINTESTINAL, Substantially Equivalent on 1993-12-14. Applicant: Primed Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Primed Instruments, Inc.
Product code: Code FCL
Device class: Class 1
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1993-08-26
Decision date: 1993-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: M9c 4h3, CA

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Recent devices under product code FCL

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K032092 — OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE2003-07-16
K973611 — SPECTRASCIENCE REUSABLE BIOPSY FORCEPS1997-12-02
K971315 — AUXILIARY INSTRUMENTS FOR URS1997-09-15
K964120 — INJECTO FLUSH1996-12-30
K963517 — SPECTRA SCIENCE BIOPSY FORCEPS1996-12-02

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.