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Alexis lighted wound protector-retractor, flexible, extra small - Alexis lighted wound protector-retractor, rigid, large (cl403)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K260982

by Applied Medical Resources Corporation

Identifiers

510(k) Number
K260982 FDA 510(k)
FDA Product Code
KGW FDA 510(k)
Models / Variants
Alexis lighted wound protector-retractor, flexible, extra small (cl312) FDA 510(k)
Alexis lighted wound protector-retractor, flexible, small (cl301) FDA 510(k)
Alexis lighted wound protector-retractor, flexible, medium (cl302) FDA 510(k)
Alexis lighted wound protector-retractor, flexible, large (cl303) FDA 510(k)
Alexis lighted wound protector-retractor, rigid, small (cl401) FDA 510(k)
Alexis lighted wound protector-retractor, rigid, medium (cl402) FDA 510(k)
Alexis lighted wound protector-retractor, rigid, large (cl403) FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4370 FDA 510(k)
Regulation Number
878.4370 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Alexis lighted wound protector-retractor, flexible, extra small - Alexis lighted wound protector-retractor, rigid, large (cl403) by Applied Medical Resources…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Applied Medical Resources Corporation

Sources (1)

  • FDA 510(k) K260982 24 fields · synced Jun 18, 2026