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510(k) K840946

MICROPOROUS HYPOALLERGENIC by Gainor Medical — Product Code KGW

K840946 is an FDA 510(k) premarket notification submitted by Gainor Medical for the device "MICROPOROUS HYPOALLERGENIC". The FDA issued a decision of Substantially Equivalent on August 17, 1984. The device falls under product code KGW (Ring (Wound Protector), Drape Retention, Internal), a Class II device regulated under 21 CFR 878.4370. Gainor Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1984
Date Received
March 5, 1984
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

Other clearances by Gainor Medical

  • K850100 — BLOOD LANCET (January 29, 1987)
  • K850150 — ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED (February 21, 1985)
  • K844306 — GAINOR MEDICAL SYRINGE (November 30, 1984)
  • K844305 — GAINOR MEDICAL FLOWMAX NEEDLES (November 30, 1984)
  • K840950 — ZINC OXIDE TAPE (October 31, 1984)
  • K840945 — SKIN CLOSURE (October 31, 1984)
  • K840951 — FIRST AID BANDAGE (October 31, 1984)
  • K840947 — CLOTH-HYPOALLERGENIC (August 17, 1984)
  • K840949 — CLEAR PLASTIC-HYPOALLERGENIC (August 17, 1984)
  • K840948 — CLEAR POROUS PLASTIC-HYPOALLERGENIC (August 14, 1984)

Other clearances for product code KGW

  • K260982 — Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis l (April 24, 2026)
  • 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)
  • K790306 — EDGE PROTECTOR, BARRIER (February 22, 1979)

FDA data resources