MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM
FDA 510(k) clearance K091107 · decided 2009-05-01
Clearance details
- K-number
- K091107
- Device name
- MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM
- Applicant
- Hemostatix Medical Technologies, LLC
- Decision
- Substantially Equivalent
- Date received
- 2009-04-16
- Decision date
- 2009-05-01
- Days to decision
- 15 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
- Bartlett, TN, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HEMOSTATIX HANDLE, FOR USE WITH MODELS 150 AND 600D HEMOSTATIX CONTROLLERS, REF 7013-5050, recall (Z-2595-2010) | Hemostatix Medical Technologies LLC | 2010-09-28 |
| MODEL P8400 HANDLE WITH INTEGRATED CABLE, FOR USE WITH MODEL P8400 CONTROLLER, REF 7013-80 recall (Z-2596-2010) | Hemostatix Medical Technologies LLC | 2010-09-28 |