ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75)
FDA 510(k) clearance K092577 · decided 2009-09-15
Clearance details
- K-number
- K092577
- Device name
- ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75)
- Applicant
- Ethicon Endo-Surgery, LLC
- Decision
- Substantially Equivalent
- Date received
- 2009-08-21
- Decision date
- 2009-09-15
- Days to decision
- 25 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
No recalls on record reference this clearance.