GELBFISH ENDO-VAC SYSTEM— 510(k) K970233

Name: FDA 510(k) clearance K970233
Creator: U.S. Food and Drug Administration
Published: 1997-10-08

Unknown

Gary A. Gelbfish

FDA 510(k) clearance K970233 for GELBFISH ENDO-VAC SYSTEM, Unknown on 1997-10-08. Applicant: Gary A. Gelbfish. Device class: 2.

Clearance details

Applicant: Gary A. Gelbfish
Product code: Code MCW
Device class: Class 2
Regulation: 21 CFR 870.4875
Advisory panel: Cardiovascular
Date received: 1997-01-21
Decision date: 1997-10-08
Decision: Unknown
Clearance type: Traditional
Location: Rockville, MD, US

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Adverse events under product code MCW

product code MCW

Death: 38
Injury: 1,386
Malfunction: 2,676
Other: 2
Total: 4,102

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.