SURGITRON— 510(k) K911461

Name: FDA 510(k) clearance K911461
Creator: U.S. Food and Drug Administration
Published: 1991-04-25

Substantially Equivalent

Ellman Intl. Mfg., Inc.

FDA 510(k) clearance K911461 for SURGITRON, Substantially Equivalent on 1991-04-25. Applicant: Ellman Intl. Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Ellman Intl. Mfg., Inc.
Product code: Code GCI
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1991-04-03
Decision date: 1991-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hewlett, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GCI

product code GCI

Malfunction: 635
Total: 635

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.