HABIB 4X
FDA 510(k) clearance K051420 · decided 2005-08-15
Clearance details
- K-number
- K051420
- Device name
- HABIB 4X
- Applicant
- Emcision , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-06-01
- Decision date
- 2005-08-15
- Days to decision
- 75 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
- London, GB
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices). AngioDynam recall (Z-3073-2011) | Angiodynamics, INC | 2011-08-24 |
| Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices). AngioDynam recall (Z-3074-2011) | Angiodynamics, INC | 2011-08-24 |
| Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distrib recall (Z-0031-06) | Rita Medical Systems | 2005-10-07 |