FDA Product Code
FDA Product Code KGW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4370
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260982 | Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403) | Applied Medical Resources Corporation | 2026-04-24 | Special | PDF ↗ |
| K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) | Applied Medical Resources Corporation | 2026-02-23 | Traditional | PDF ↗ |
| K113268 | ALEXIS O WOUND PROTECTOR/RETRACTOR | Applied Medical Resources Corp. | 2013-02-08 | Traditional | PDF ↗ |
| K100120 | ALEXIS ORTHOPAEDIC WOUND RETRACTOR | Applied Medical Resources Corp. | 2010-04-02 | Traditional | PDF ↗ |
| K093296 | ALEXIS LAPAROSCOPIC SYSTEM | Applied Medical Resources Corp. | 2009-11-05 | Traditional | PDF ↗ |
| K062907 | ALEXIS WOUND RETRACTOR | Applied Medical Resources | 2007-01-09 | Traditional | PDF ↗ |
| K041711 | ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304 | Applied Medical Resources Corp. | 2004-08-26 | Traditional | PDF ↗ |
| K840946 | MICROPOROUS HYPOALLERGENIC | Gainor Medical | 1984-08-17 | Traditional | PDF ↗ |
| K790306 | EDGE PROTECTOR, BARRIER | Surgikos, Inc. | 1979-02-22 | Traditional | PDF ↗ |
Product code KGW · Class II · General, Plastic Surgery. Data: openFDA.