Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle— 510(k) K213831

Substantially Equivalent

Gyrus Acmi, Inc.

FDA 510(k) clearance K213831 for Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle, Substantially Equivalent on 2022-01-04. Applicant: Gyrus Acmi, Inc..

Clearance details

Applicant: Gyrus Acmi, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2021-12-08
Decision date: 2022-01-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Westborough, MA, US

Download summary PDF View on FDA.gov ↗

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.