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510(k) K951861

STERICARE WOUND CARE GEL by Acacia Laboratories, Inc. — Product Code MGQ

K951861 is an FDA 510(k) premarket notification submitted by Acacia Laboratories, Inc. for the device "STERICARE WOUND CARE GEL". The FDA issued a decision of Substantially Equivalent on Jul 11, 1995. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), a Class U device. Acacia Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 11, 1995
Date Received
Apr 21, 1995
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 Acacia Laboratories, Inc.

  • K952419 — STERIGAUZE GEL DRESSING (Jul 26, 1995)
  • K952420 — STERIGAUZE WET DRESSING (Jul 12, 1995)
  • K952414 — PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER (Jun 23, 1995)
  • K951914 — HYDRACARE ABSORBENT WOUND DRESSING (May 15, 1995)
  • K950344 — HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER (Mar 24, 1995)
  • K913408 — STERILE PLASTIC DRAPE (Mar 12, 1992)
  • K901761 — STERILE SUCTION TUBING SET (May 7, 1990)
  • K892856 — NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS (Nov 8, 1989)
  • K892804 — NEWCHILL(TM) CARDIAC INSULATOR (Jul 14, 1989)
  • K884055 — SURGI-TAG(TM) STERILE LABEL SETS (Oct 13, 1988)

Other clearances for product code MGQ

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

FDA data resources