Home / 510(k) Clearances / K260982

510(k) K260982

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) by Applied Medical Resources Corporation — Product Code KGW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2026
Date Received
March 25, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ring (Wound Protector), Drape Retention, Internal
Device Class
Class II
Regulation Number
878.4370
Review Panel
SU
Submission Type

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  • K220969 — GelPOINT V-Path Vaginal Access System (September 16, 2022)
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  • K202049 — Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter (September 7, 2021)
  • K190331 — Applied Medical Laparoscopic Linear Cutter (November 22, 2019)
  • K180699 — Voyant Open Fusion Device (April 13, 2018)
  • K172624 — Voyant 5mm Fusion Device (February 13, 2018)

Other clearances for product code KGW

  • K253531 — Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighte (February 23, 2026)
  • K113268 — ALEXIS O WOUND PROTECTOR/RETRACTOR (February 8, 2013)
  • K100120 — ALEXIS ORTHOPAEDIC WOUND RETRACTOR (April 2, 2010)
  • K093296 — ALEXIS LAPAROSCOPIC SYSTEM (November 5, 2009)
  • K062907 — ALEXIS WOUND RETRACTOR (January 9, 2007)
  • K041711 — ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304 (August 26, 2004)
  • K840946 — MICROPOROUS HYPOALLERGENIC (August 17, 1984)
  • K790306 — EDGE PROTECTOR, BARRIER (February 22, 1979)