VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)— 510(k) K973558

Substantially Equivalent

Ultracell Medical Technologies, Inc.

FDA 510(k) clearance K973558 for VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS), Substantially Equivalent on 1997-11-24. Applicant: Ultracell Medical Technologies, Inc..

Clearance details

Applicant: Ultracell Medical Technologies, Inc.
Product code: Code FEB
Advisory panel: Gastroenterology, Urology
Date received: 1997-09-19
Decision date: 1997-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Stonington, CT, US

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Adverse events under product code FEB

product code FEB

Malfunction: 3,879
Total: 3,879

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.