GENESIS INSUFFLATING CATHETER— 510(k) K903669

Name: FDA 510(k) clearance K903669
Creator: U.S. Food and Drug Administration
Published: 1990-09-12

Substantially Equivalent

General Medical Co.

FDA 510(k) clearance K903669 for GENESIS INSUFFLATING CATHETER, Substantially Equivalent on 1990-09-12. Applicant: General Medical Co.. Device class: 1.

Clearance details

Applicant: General Medical Co.
Product code: Code BSY
Device class: Class 1
Regulation: 21 CFR 868.6810
Advisory panel: Anesthesiology
Date received: 1990-08-13
Decision date: 1990-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BSY

product code BSY

Death: 3
Injury: 155
Malfunction: 959
Total: 1,117

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.