AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY
FDA 510(k) clearance K101444 · decided 2010-06-14
Clearance details
- K-number
- K101444
- Device name
- AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY
- Applicant
- Surgical Devices, A Global Business Unit Tyco
- Decision
- Substantially Equivalent
- Date received
- 2010-05-24
- Decision date
- 2010-06-14
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- GDW
- Device class
- 2
- Regulation number
- 878.4750
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- North Haven, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.