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.
Clearance details
- Applicant
- Cambridge Endoscopic Devices
- Product code
- Code GEI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
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.