Jewel Soft Tissue Reinforcement Device (102-6005)
FDA 510(k) clearance K242237 · decided 2025-07-15
Clearance details
- K-number
- K242237
- Device name
- Jewel Soft Tissue Reinforcement Device (102-6005)
- Applicant
- Xiros Limited
- Decision
- Substantially Equivalent
- Date received
- 2024-07-30
- Decision date
- 2025-07-15
- Days to decision
- 350 days
- Clearance type
- Traditional
- Product code
- QUW
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Yeadon, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Xiros Limited
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TekBrace Solo Soft Tissue Reinforcement Device (K261621) | Theramicro | 2026-06-09 |
| TekBrace Solo Soft Tissue Reinforcement Device (K251063) | Theramicro | 2025-05-30 |
| Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (K222978) | Xiros, Ltd. | 2022-12-27 |
Recalls involving this device
No recalls on record reference this clearance.