Tisuthes e-PTFE Surgical Patch
FDA 510(k) clearance K201153 · decided 2023-06-13
Clearance details
- K-number
- K201153
- Device name
- Tisuthes e-PTFE Surgical Patch
- Applicant
- Shanghai Suokang Medical Implants Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-04-30
- Decision date
- 2023-06-13
- Days to decision
- 1139 days
- Clearance type
- Traditional
- Product code
- OWR
- Device class
- 2
- Regulation number
- 878.3300
- 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.