CHOLANGIOGRAPHY CLAMP— 510(k) K924480

Name: FDA 510(k) clearance K924480
Creator: U.S. Food and Drug Administration
Published: 1993-03-03

Substantially Equivalent

Applied Medical Resources

FDA 510(k) clearance K924480 for CHOLANGIOGRAPHY CLAMP, Substantially Equivalent on 1993-03-03. Applicant: Applied Medical Resources. Device class: 1.

Clearance details

Applicant: Applied Medical Resources
Product code: Code GBZ
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1992-09-03
Decision date: 1993-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Launa Hills, CA, US

Download summary PDF View on FDA.gov ↗

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K942450 — ENDOPATH1994-08-05
K932228 — MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER1993-08-10
K926217 — TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE1993-07-13

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Adverse events under product code GBZ

product code GBZ

Death: 2
Total: 2

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.