DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR
FDA 510(k) clearance K131511 · decided 2013-07-05
Clearance details
- K-number
- K131511
- Device name
- DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR
- Applicant
- Changzhou Sinolinks Medical Innovation Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-05-28
- Decision date
- 2013-07-05
- Days to decision
- 38 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
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.