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510(k) K093296

ALEXIS LAPAROSCOPIC SYSTEM by Applied Medical Resources Corp. — Product Code KGW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2009
Date Received
October 21, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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

  • 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)
  • 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)