FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
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)
K Number: K260982
·
Decision Apr 24, 2026
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
8
Applicant Total
12
Review Days
30
Basic Information
- 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); Alexis lighted wound protector-retractor, rigid, large (cl403)
- K Number
- K260982
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Applied Medical Resources Corporation
- Date Received
- March 25, 2026
- Decision Date
- April 24, 2026
- Product Code
- KGW
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KGW | Ring (Wound Protector), Drape Retention, Internal | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGW), ordered by most recent decision date.
Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALEXIS O WOUND PROTECTOR/RETRACTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALEXIS ORTHOPAEDIC WOUND RETRACTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALEXIS LAPAROSCOPIC SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALEXIS WOUND RETRACTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Applied Medical Resources Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) | Feb 23, 2026 | Substantially Equivalent |
| K252412 | Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) | Oct 31, 2025 | Substantially Equivalent |
| K232880 | Inzii Ripstop Redeployable Retrieval System | Nov 1, 2023 | Substantially Equivalent |
| K222284 | Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) | Oct 14, 2022 | Substantially Equivalent |
| K220969 | GelPOINT V-Path Vaginal Access System | Sep 16, 2022 | Substantially Equivalent |
| K211043 | Alexis Contained Extraction System | Mar 31, 2022 | Substantially Equivalent |
| K202049 | Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter | Sep 7, 2021 | Substantially Equivalent |
| K190331 | Applied Medical Laparoscopic Linear Cutter | Nov 22, 2019 | Substantially Equivalent |
| K180699 | Voyant Open Fusion Device | Apr 13, 2018 | Substantially Equivalent |
| K172624 | Voyant 5mm Fusion Device | Feb 13, 2018 | Substantially Equivalent |