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510(k) K072560

ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) by Teikoku Pharma USA, Inc. — Product Code NAD

K072560 is an FDA 510(k) premarket notification submitted by Teikoku Pharma USA, Inc. for the device "ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)". The FDA issued a decision of Substantially Equivalent on June 17, 2008. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2008
Date Received
September 11, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
Submission Type

Other clearances for product code NAD

  • K102403 — SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL (March 3, 2011)
  • K091133 — APLION TOPICAL CARE SYSTEM (May 20, 2009)
  • K080524 — CENTURION SORBAVIEW OTC (April 23, 2008)
  • K060046 — DERMASTREAM (February 27, 2006)
  • K043063 — OXYBAND WOUND DRESSING (March 24, 2005)
  • K020781 — WET CHAMBER (May 6, 2002)
  • K990530 — KERLIX MD ANTIMICROBIAL GAUZE DRESSING (January 31, 2000)
  • K990861 — WOUND DRESSING/ABD PAD, MODEL #10810 (April 12, 1999)
  • K964534 — OTOSILK OTOLOGICAL GRAFT DRESSING (April 9, 1997)
  • K960815 — DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSIN (April 29, 1996)

FDA data resources