5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Monopolar cable with 4mm pin, Monopolar cable with 8mm pin— 510(k) K142868

Substantially Equivalent

Purple Surgical International Limited

FDA 510(k) clearance K142868 for 5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Monopolar cable with 4mm pin, Monopolar cable with 8mm pin, Substantially Equivalent on 2014-11-21. Applicant: Purple Surgical International Limited.

Clearance details

Applicant: Purple Surgical International Limited
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2014-10-01
Decision date: 2014-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenley, GB

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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.