PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
FDA 510(k) clearance K051301 · decided 2005-08-30
Clearance details
- K-number
- K051301
- Device name
- PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
- Applicant
- Ethicon Endo-Surgery, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-05-19
- Decision date
- 2005-08-30
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- GDW
- Device class
- 2
- Regulation number
- 878.4750
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE HCS Hemorr recall (Z-0057-2013) | Ethicon Endo-Surgery Inc | 2012-10-13 |
| Proximate PPH, Procedure for Prolapse and Hemmorroids Set, REF PPH03. Each set contains: 1 recall (Z-0980-2007) | Ethicon Endo-Surgery Inc | 2007-06-28 |