HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO— 510(k) K911341

Substantially Equivalent

Ultracision, Inc.

FDA 510(k) clearance K911341 for HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO, Substantially Equivalent on 1991-06-24. Applicant: Ultracision, Inc..

Clearance details

Applicant: Ultracision, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1991-03-26
Decision date: 1991-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Attleboro, MA, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.