ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER
FDA 510(k) clearance K961390 · decided 1996-06-25
Clearance details
- K-number
- K961390
- Device name
- ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER
- Applicant
- Ethicon Endo-Surgery, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-10
- Decision date
- 1996-06-25
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- OCW
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Standar recall (Z-0212-04) | Ethicon Endo-Surgery | 2003-12-17 |
| Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Vascula recall (Z-0213-04) | Ethicon Endo-Surgery | 2003-12-17 |