BIOPSY FORCEPS— 510(k) K914497

Name: FDA 510(k) clearance K914497
Creator: U.S. Food and Drug Administration
Published: 1992-01-03

Substantially Equivalent

Surgitek Medical Engineering Corp.

FDA 510(k) clearance K914497 for BIOPSY FORCEPS, Substantially Equivalent on 1992-01-03. Applicant: Surgitek Medical Engineering Corp.. Device class: 1.

Clearance details

Applicant: Surgitek Medical Engineering Corp.
Product code: Code FCL
Device class: Class 1
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1991-10-08
Decision date: 1992-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Racine, WI, US

Download summary PDF View on FDA.gov ↗

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

More clearances from Surgitek Medical Engineering Corp.

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K914504 — CYTOLOGY BRUSH1992-02-18
K914495 — E.R.C.P. CATHETER1992-01-30
K914505 — STONE BASKET1991-12-09
K914496 — SCLEROTHERAPY NEEDLE1991-12-05
K914503 — GRASPING FORCEPS1991-12-05

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.