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FDA 510(k)

Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)

K-Number: K253531 · 2026-02-23

ApplicantApplied Medical Resources Corporation
Decision Date2026-02-23
Product CodeKGW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2026-02-23 under 510(k) number K253531. The device is classified under product code KGW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)?

Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) is a medical device that received FDA 510(k) clearance on 2026-02-23. The listed applicant is Applied Medical Resources Corporation. The 510(k) number is K253531.

When did Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) receive FDA 510(k) clearance?

Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) received FDA 510(k) clearance on 2026-02-23, under 510(k) number K253531.

Who is the listed applicant for Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)?

The FDA 510(k) record lists Applied Medical Resources Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)?

The FDA product code for Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) is KGW.

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Other records listing Applied Medical Resources Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260982Alexis 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)K252740Voyant® Open Fusion Device (EB240/Open Fusion)K252442Kii Structural Balloon Access SystemK252412Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)K243152GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceK232880Inzii Ripstop Redeployable Retrieval System

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Related Devices (Code: KGW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260982Alexis 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)Applied Medical Resources Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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