Panels › General, Plastic Surgery › Product code KGW · Class 2
Ring (Wound Protector), Drape Retention, Internal
Regulation 878.4370
2510(k)s in 12 months (9 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KGW
| Company | 510(k)s | Recalls |
|---|---|---|
| Applied Medical Resources | 7 | 0 |
| Gainor Medical | 1 | 0 |
| Surgikos, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 24, 2026 | K260982 | Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexib Applied Medical Resources Corporation | KGW |
| Feb 23, 2026 | K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, M Applied Medical Resources Corporation | KGW |
| Feb 8, 2013 | K113268 | ALEXIS O WOUND PROTECTOR/RETRACTOR Applied Medical Resources Corp. | KGW |
| Apr 2, 2010 | K100120 | ALEXIS ORTHOPAEDIC WOUND RETRACTOR Applied Medical Resources Corp. | KGW |
| Nov 5, 2009 | K093296 | ALEXIS LAPAROSCOPIC SYSTEM Applied Medical Resources Corp. | KGW |
| Jan 9, 2007 | K062907 | ALEXIS WOUND RETRACTOR Applied Medical Resources | KGW |
| Aug 26, 2004 | K041711 | ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304 Applied Medical Resources Corp. | KGW |
| Aug 17, 1984 | K840946 | MICROPOROUS HYPOALLERGENIC Gainor Medical | KGW |
| Feb 22, 1979 | K790306 | EDGE PROTECTOR, BARRIER Surgikos, Inc. | KGW |
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