Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler
FDA 510(k) clearance K150026 · decided 2015-05-18
Clearance details
- K-number
- K150026
- Device name
- Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler
- Applicant
- Ethicon Endo-Surgery, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-01-07
- Decision date
- 2015-05-18
- Days to decision
- 131 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
- Guaynabo, PR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.