TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE— 510(k) K926217

Name: FDA 510(k) clearance K926217
Creator: U.S. Food and Drug Administration
Published: 1993-07-13

Substantially Equivalent

Terumo Medical Corp.

FDA 510(k) clearance K926217 for TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE, Substantially Equivalent on 1993-07-13. Applicant: Terumo Medical Corp.. Device class: 1.

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code GBZ
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1992-12-10
Decision date: 1993-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

Download summary PDF View on FDA.gov ↗

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K932228 — MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER1993-08-10
K924212 — STRYKER ENDOSCOPY CHOLANGIOGRAM KIT1993-07-07

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K110540 — TERUMO SUPPORT CATHETER2011-05-13
K102008 — GLIDESHEATH2010-07-21
K091329 — PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH2009-05-29

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.