K221495 is an FDA 510(k) clearance for the SOLID CLIP™ Single Use Clip Applier. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).
Submitted by Medscope Biotech Co., Ltd. (Miaoli County, TW). The FDA issued a Cleared decision on July 18, 2024, 787 days after receiving the submission on May 23, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K221495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2022 |
| Decision Date | July 18, 2024 |
| Days to Decision | 787 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FZP - Clip, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4300 |