SOLID CLIP™ Single Use Clip Applier
FDA 510(k) clearance K221495 · decided 2024-07-18
Clearance details
- K-number
- K221495
- Device name
- SOLID CLIP™ Single Use Clip Applier
- Applicant
- Medscope Biotech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-05-23
- Decision date
- 2024-07-18
- Days to decision
- 787 days
- Clearance type
- Traditional
- Product code
- FZP
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Miaoli County, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.