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); A
FDA 510(k) K260982 · Applied Medical Resources Corporation
510(k) numberK260982
Submission
- Device name
- 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); A
- Applicant
- Applied Medical Resources Corporation
Rancho Santa, CA, US - Received
- March 25, 2026
- Decision date
- April 24, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KGW – Ring (Wound Protector), Drape Retention, Internal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KGW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Surgikos, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound…KGW · Traditional | 02/23/2026SE |
| K252740 | Voyant® Open Fusion Device (EB240/Open Fusion)GEI · Special | 11/04/2025SE |
| K252442 | Kii Structural Balloon Access SystemGCJ · Traditional | 10/31/2025SE |
| K252412 | Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)GEI · Traditional | 10/31/2025SE |
| K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceHEW · Traditional | 10/02/2025SE |
| K232880 | Inzii Ripstop Redeployable Retrieval SystemGCJ · Special | 11/01/2023SE |
| K222284 | Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)GEI · Special | 10/14/2022SE |
| K220969 | GelPOINT V-Path Vaginal Access SystemMOK · Traditional | 09/16/2022SE |
| K211043 | Alexis Contained Extraction SystemGCJ · Traditional | 03/31/2022SE |
| K202049 | Python Catheter/Over-the-Wire Latis Graft Cleaning CatheterDXE · Special | 09/07/2021SE |
Questions and answers
When was 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); A cleared by the FDA?
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); A (K260982) received a 510(k) decision of Substantially Equivalent on April 24, 2026, 30 days after the submission was received.
What is the product code of K260982?
The FDA product code is KGW – Ring (Wound Protector), Drape Retention, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.4370.