DISPOSABLE RE-NEW FORCEPS— 510(k) K981389

Substantially Equivalent

Microline Pentax, Inc.

FDA 510(k) clearance K981389 for DISPOSABLE RE-NEW FORCEPS, Substantially Equivalent on 1998-05-29. Applicant: Microline Pentax, Inc..

Clearance details

Applicant: Microline Pentax, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1998-04-16
Decision date: 1998-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wellesley, 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.