ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO
FDA 510(k) clearance K111111 · decided 2011-06-08
Clearance details
- K-number
- K111111
- Device name
- ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO
- Applicant
- Ethicon Endo-Surgery, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-04-20
- Decision date
- 2011-06-08
- Days to decision
- 49 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 |
|---|---|---|
| Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH ETS-Flex Endosc recall (Z-0295-2017) | Ethicon Endo-Surgery Inc | 2016-10-20 |
| Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOPATH ETS-Flex E recall (Z-0296-2017) | Ethicon Endo-Surgery Inc | 2016-10-20 |