PUREWRIST SCISSORS, MODEL PW1101-01; PUREWRIST DISSECTOR, MODEL PW1201-01; PUREWRIST HOOK, MODEL PW1301-01— 510(k) K061425
Substantially EquivalentCambridge 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
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- 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, through . 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.