ENDOPATH ENDOSCOPIC INSTRUMENTS
FDA 510(k) clearance K984240 · decided 1999-06-22
Clearance details
- K-number
- K984240
- Device name
- ENDOPATH ENDOSCOPIC INSTRUMENTS
- Applicant
- Ethicon Endo-Surgery, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-11-27
- Decision date
- 1999-06-22
- Days to decision
- 207 days
- Clearance type
- Abbreviated
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- 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 |
|---|---|---|
| Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD, Ethicon recall (Z-0565-2008) | Ethicon Endo-Surgery Inc | 2008-01-29 |