Company ยท GB
Xiros, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2025. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FTL | Mesh, Surgical, Polymeric | 3 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 |
| HXJ | Staple Driver | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 |
| QUW | Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament | 2 |
| HTN | Washer, Bolt Nut | 1 |
| HTY | Pin, Fixation, Smooth | 1 |
| JDR | Staple, Fixation, Bone | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 15, 2025 | K242237 | Jewel Soft Tissue Reinforcement Device (102-6005) Xiros Limited, GB | QUW |
| May 31, 2023 | K230671 | Pitch PaSoft Tissue Reinforcement Device Xiros, Ltd., GB | FTL |
| Dec 27, 2022 | K222978 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device Xiros, Ltd., GB | QUW |
| Aug 26, 2022 | K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device Xiros, Ltd., GB | FTL |
| Jul 22, 2022 | K220906 | SECURE-LOCK Xiros, Ltd., GB | HTY |
| Aug 13, 2021 | K211563 | Pitch-Patchs Xiros, Ltd., GB | FTL |
| Jul 17, 2019 | K191053 | Xtreme-Loop Xiros, Ltd., GB | MBI |
| Apr 3, 2018 | K180243 | Infinity-Lock Button System Xiros, Ltd., GB | HTN |
| Jun 30, 2017 | K171680 | Infinity-Lock 3, Infinity-Lock 5 Xiros, Ltd., GB | GAT |
| Sep 9, 2015 | K151601 | SECURE-LOOP Xiros, Ltd., GB | MBI |
| Aug 28, 2001 | K002172 | POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) Xiros Plc, GB | GAT |
| Jul 13, 2001 | K010051 | POLY-TAPES WITH THE FASTLOK FIXATION DEVICE Xiros Plc, GB | JDR |