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510(k) K945313

SPARTA HYDROGEL WOUND DRESSING by Sparta Surgical Corp. — Product Code MGQ

K945313 is an FDA 510(k) premarket notification submitted by Sparta Surgical Corp. for the device "SPARTA HYDROGEL WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on January 12, 1995. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), a Class U device. Sparta Surgical Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1995
Date Received
November 1, 1994
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 Sparta Surgical Corp.

  • K965187 — SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD (August 1, 1997)
  • K922729 — SPARTA WET DRESSING, SODIUM CHLORIDE (November 23, 1992)
  • K905384 — DAVID SIMMONDS ANESTHESIA EXTENSION TUBES (March 22, 1991)
  • K905240 — VESSELOOPS (February 6, 1991)
  • K896085 — SURGI-BRUSH (November 8, 1989)
  • K896084 — MICROSPEARS (November 2, 1989)

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