CryoThin™ Surgical System and Accessories
FDA 510(k) clearance K231661 · decided 2023-11-27
Clearance details
- K-number
- K231661
- Device name
- CryoThin™ Surgical System and Accessories
- Applicant
- Medinux (Tianjin) Technologies Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-06-07
- Decision date
- 2023-11-27
- Days to decision
- 173 days
- Clearance type
- Traditional
- Product code
- GEH
- Device class
- 2
- Regulation number
- 878.4350
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Tianjin, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.