FDA Product Code
FDA Product Code QUW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3300
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262729 | TeKBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2026-08-18 | Special | PDF ↗ |
| K261621 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2026-06-09 | Special | PDF ↗ |
| K242237 | Jewel Soft Tissue Reinforcement Device (102-6005) | Xiros Limited | 2025-07-15 | Traditional | PDF ↗ |
| K251063 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2025-05-30 | Traditional | PDF ↗ |
| K222978 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022-12-27 | Traditional | PDF ↗ |
Product code QUW · Class II · General, Plastic Surgery. Data: openFDA.