PUREWRIST SCISSORS, MODEL PW1101-01; PUREWRIST DISSECTOR, MODEL PW1201-01; PUREWRIST HOOK, MODEL PW1301-01— 510(k) K061425

Name: FDA 510(k) clearance K061425
Creator: U.S. Food and Drug Administration
Published: 2006-08-10

Substantially Equivalent

Cambridge Endoscopic Devices

FDA 510(k) clearance K061425 for PUREWRIST SCISSORS, MODEL PW1101-01; PUREWRIST DISSECTOR, MODEL PW1201-01; PUREWRIST HOOK, MODEL PW1301-01, Substantially Equivalent on 2006-08-10. Applicant: Cambridge Endoscopic Devices. Device class: 2.

Clearance details

Device name as filed: PUREWRIST SCISSORS, MODEL PW1101-01;PUREWRIST DISSECTOR, MODEL PW1201-01;PUREWRIST HOOK, MODEL PW1301-01
Applicant: Cambridge Endoscopic Devices
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2006-05-23
Decision date: 2006-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, 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.