510(k) K260982
- Device
- 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)
- Applicant
- Applied Medical Resources Corporation
- 510(k) number
- K260982
- Product code
- KGW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-24
- Date received
- 2026-03-25
- Regulation
- 878.4370
- Classification name
- Ring (Wound Protector), Drape Retention, Internal
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Apeksha Shanbhag
- Address
- 22872 Avenida Empresa Rancho Santa CA US 92688 92688
FDA Registration Numbers#
- 3031757047
- 3007791595
- 9616088
- 1061124
- 3009763019
- 2245304
- 1423537
- 3031841433
- 3015497424
- 8010697
- 3016615875
- 3042272797
- 8030672
- 9611481
- 3041276890
- 9680284
- 3016678045
- 3017194442
- 1921846
- 3008191256
- 3014461810
- 3009750712
- 1721686
- 3010601984
- 3009051888
- 3010288357
- 2245539
- 3004111573
- 2027111
Source Documents#
Other 510(k) Records For Product Code KGW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) | Applied Medical Resources Corporation | 2026-02-23 |
| K113268 | ALEXIS O WOUND PROTECTOR/RETRACTOR | Applied Medical Resources Corp. | 2013-02-08 |
| K100120 | ALEXIS ORTHOPAEDIC WOUND RETRACTOR | Applied Medical Resources Corp. | 2010-04-02 |
| K093296 | ALEXIS LAPAROSCOPIC SYSTEM | Applied Medical Resources Corp. | 2009-11-05 |
| K062907 | ALEXIS WOUND RETRACTOR | Applied Medical Resources | 2007-01-09 |
| K041711 | ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304 | Applied Medical Resources Corp. | 2004-08-26 |
| K840946 | MICROPOROUS HYPOALLERGENIC | Gainor Medical | 1984-08-17 |
| K790306 | EDGE PROTECTOR, BARRIER | Surgikos, Inc. | 1979-02-22 |