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510(k) K024054

XYLOS XCELL ANTIMICROBIAL DRESSING by Xylos Corporation — Product Code MGQ

K024054 is an FDA 510(k) premarket notification submitted by Xylos Corporation for the device "XYLOS XCELL ANTIMICROBIAL DRESSING". The FDA issued a decision of Substantially Equivalent on March 7, 2003. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), a Class U device. Xylos Corporation has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2003
Date Received
December 9, 2002
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 Xylos Corporation

  • K111584 — XYLOS MACRO-POROUS SURGICAL MESH (August 25, 2011)
  • K100984 — XYLOS VESSEL GUARD (July 7, 2010)
  • K090880 — XYLOS POROUS SURGICAL MESH (May 27, 2009)
  • K090778 — MTA PROTECTIVE SHEET (April 28, 2009)
  • K083823 — SECURIAN TISSUE REINFORCEMENT MATRIX (March 18, 2009)
  • K081882 — MODIFICATION TO XYLOS SURGICAL MESH (July 11, 2008)
  • K023237 — XYLOS SURGICAL MESH (March 18, 2003)
  • K974251 — X-CELL WOUND DRESSING (June 22, 1998)

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)
  • K022584 — CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING (December 30, 2002)
  • K022995 — COLLATEK HYDROGEL (December 2, 2002)

FDA data resources