Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K113591
COLS PEEK · Fournitures Hospitalieres Industrie · decided 2011-12-22 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Chopping block | 256217 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489562174 |
| CoLS Bone Tap | 250105 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489501050 |
| Tendon hook | 265642 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489656422 |
| CoLS retrograde reamer D11 | 251831 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489518317 |
| CoLS retrograde reamer D7 | 253165 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489531651 |
| Femoral ACL Universal guide | 255694 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489556944 |
| Universal guide container | 256034 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489560347 |
| CoLS upper tray V5 | 264938 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489649387 |
| BROCHE 23CM 2,4MM BOUT MECHE BOUT ROND (teknomedical) | 255994 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489559945 |
| CoLS Open Tendon Stripper | 265664 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489656644 |
| CoLS PCL femoral guide V5 | 264929 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489649295 |
| CoLS suture passer | 256010 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489560101 |
| CoLS PCL tibial guide V5 | 264928 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489649288 |
| Stripper ouvert | 265644 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489656446 |
| Universal guide double tunnel assembly | 255699 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489556999 |
| Universal guide handle assembly | 255698 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489556982 |
| BROCHE 25CM 2,4MM BOUT MECHE BOUT ROND (Teknomedical) | 257380 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489573804 |
| CoLS Tape cutter razor blade | 265597 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489655975 |
| CoLS ® | 266636 - CoLS® disposable instruments | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489666360 |
| CoLS Container V5 | 264935 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489649356 |
| Container | 256008 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489560088 |
| CoLS workstation U-Handle lever assembly | 256012 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489560125 |
| Wire for screw TLS D 1,8 LG 220mm | 255970 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489559709 |
| Cannulated reamer Diameter 4,5 | 251262 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489512629 |
| CoLS workstation body | 256013 | FOURNITURES HOSPITALIERES INDUSTRIE | HWC MBI | 03661489560132 |