Ring (Wound Protector), Drape Retention, Internal
FDA product code KGW · Class II (moderate risk) · 21 CFR 878.4370 · General, Plastic Surgery
9510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260982 | Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted…KGW · Special | Applied Medical Resources Corporation | 04/24/2026SE |
| K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound…KGW · Traditional | Applied Medical Resources Corporation | 02/23/2026SE |
| K113268 | Alexis O Wound Protector/RetractorKGW · Traditional | Applied Medical Resources Corp. | 02/08/2013SE |
| K100120 | Alexis Orthopaedic Wound RetractorKGW · Traditional | Applied Medical Resources Corp. | 04/02/2010SE |
| K093296 | Alexis Laparoscopic SystemKGW · Traditional | Applied Medical Resources Corp. | 11/05/2009SE |
| K062907 | Alexis Wound RetractorKGW · Traditional | Applied Medical Resources | 01/09/2007SE |
| K041711 | Alexis Wound Retractor, Models C8312, C8301, C8302, C8303, C8304KGW · Traditional | Applied Medical Resources Corp. | 08/26/2004SE |
| K840946 | Microporous HypoallergenicKGW · Traditional | Gainor Medical | 08/17/1984SE |
| K790306 | Edge Protector, BarrierKGW · Traditional | Surgikos, Inc. | 02/22/1979SE |