CATHETER, CHOLANGIOGRAM, OPERATIVE— 510(k) K772288

Name: FDA 510(k) clearance K772288
Creator: U.S. Food and Drug Administration
Published: 1978-01-30

Substantially Equivalent

Gesco Intl., Inc.

FDA 510(k) clearance K772288 for CATHETER, CHOLANGIOGRAM, OPERATIVE, Substantially Equivalent on 1978-01-30. Applicant: Gesco Intl., Inc.. Device class: 1.

Clearance details

Applicant: Gesco Intl., Inc.
Product code: Code GBZ
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1977-12-12
Decision date: 1978-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GBZ

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K973621 — PRE-VIEW CHOLANGIOGRAPHY CLAMP1997-12-17
K944790 — FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER1994-11-29
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.