PRE-VIEW CHOLANGIOGRAPHY CLAMP— 510(k) K973621

Name: FDA 510(k) clearance K973621
Creator: U.S. Food and Drug Administration
Published: 1997-12-17

Substantially Equivalent

Nashville Surgical Instruments

FDA 510(k) clearance K973621 for PRE-VIEW CHOLANGIOGRAPHY CLAMP, Substantially Equivalent on 1997-12-17. Applicant: Nashville Surgical Instruments. Device class: 1.

Clearance details

Applicant: Nashville Surgical Instruments
Product code: Code GBZ
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1997-09-23
Decision date: 1997-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Springfield, TN, US

Download summary PDF View on FDA.gov ↗

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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.