PUREWRIST SCISSORS, MODEL PW1101-01;PUREWRIST DISSECTOR, MODEL PW1201-01;PUREWRIST HOOK, MODEL PW1301-01
FDA 510(k) clearance K061425 · decided 2006-08-10
Clearance details
- K-number
- K061425
- Device name
- PUREWRIST SCISSORS, MODEL PW1101-01;PUREWRIST DISSECTOR, MODEL PW1201-01;PUREWRIST HOOK, MODEL PW1301-01
- Applicant
- Cambridge Endoscopic Devices
- Decision
- Substantially Equivalent
- Date received
- 2006-05-23
- Decision date
- 2006-08-10
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cambridge Endoscopic Autonomy Laparo-Angle 5mm Metzenbaum Scissors with Monopolar Cautery, recall (Z-2743-2011) | Cambridge Endoscopic Devices, Incorporated | 2011-07-06 |
| Cambridge Endoscopic Autonomy Laparo-Angle 5mm Metzenbaum Scissors with Monopolar Cautery, recall (Z-2744-2011) | Cambridge Endoscopic Devices, Incorporated | 2011-07-06 |