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510(k) K990368

DUODERM HYDROACTIVE GEL WOUND DRESSING by Convatec, A Bristol-Myers Squibb Co. — Product Code MGQ

K990368 is an FDA 510(k) premarket notification submitted by Convatec, A Bristol-Myers Squibb Co. for the device "DUODERM HYDROACTIVE GEL WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on March 26, 1999. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), a Class U device. Convatec, A Bristol-Myers Squibb Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1999
Date Received
February 8, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Convatec, A Bristol-Myers Squibb Co.

  • K032734 — CONVATEC FECAL MANAGEMENT SYSTEM (April 8, 2004)
  • K982116 — AQUACEL HYDROFIBER WOUND DRESSING (September 8, 1998)
  • K973806 — DUODERM HYDROACTIVE GEL (December 29, 1997)
  • K973807 — DUODERM HYDROACTIVE PASTE (December 23, 1997)
  • K973717 — COMBIDERM ACD (December 17, 1997)
  • K973716 — DUODERM EXTRA THIN CGF DRESSING (December 17, 1997)
  • K954918 — COMBIDERM ACD (December 26, 1995)
  • K942941 — CONQUEST MALE CONTINENCE SYSTEM (March 17, 1995)
  • K940895 — EPIVIEW (November 22, 1994)

Other clearances for product code MGQ

  • K171879 — HylaGuard Moisturizing Cream (October 16, 2017)
  • K083024 — HYLATOPIC EMOLLIENT FOAM (March 27, 2009)
  • K041342 — IMPRUV A.I. CREAM WOUND AND SKIN EMULSION (July 19, 2005)
  • K041268 — SILVERSITE OR CALGITROL (September 20, 2004)
  • K040019 — SILVERSEAL (July 23, 2004)
  • K040517 — TENDERWET ACTIVE (March 25, 2004)
  • K022587 — MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS (August 22, 2003)
  • K024367 — SINCLAIR WOUND AND SKIN EMULSION (July 28, 2003)
  • K024054 — XYLOS XCELL ANTIMICROBIAL DRESSING (March 7, 2003)
  • K022584 — CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING (December 30, 2002)

FDA data resources