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510(k) K253531

Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) by Applied Medical Resources Corporation — Product Code KGW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2026
Date Received
November 13, 2025
Clearance Type
Traditional
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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Other clearances for product code KGW

  • 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)