ULTRACELL SUCTION SPONGE— 510(k) K972635

Substantially Equivalent

Ultracell Medical Technologies, Inc.

FDA 510(k) clearance K972635 for ULTRACELL SUCTION SPONGE, Substantially Equivalent on 1997-10-01. Applicant: Ultracell Medical Technologies, Inc..

Clearance details

Applicant: Ultracell Medical Technologies, Inc.
Product code: Code GBX
Advisory panel: General, Plastic Surgery
Date received: 1997-07-14
Decision date: 1997-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Stonington, CT, US

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Adverse events under product code GBX

product code GBX

Death: 16
Injury: 583
Malfunction: 3,578
Other: 1
Total: 4,178

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.