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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 July 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
July 11, 1995
Date Received
April 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 (July 26, 1995)
  • K952420 — STERIGAUZE WET DRESSING (July 12, 1995)
  • K952414 — PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER (June 23, 1995)
  • K951914 — HYDRACARE ABSORBENT WOUND DRESSING (May 15, 1995)
  • K950344 — HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER (March 24, 1995)
  • K913408 — STERILE PLASTIC DRAPE (March 12, 1992)
  • K901761 — STERILE SUCTION TUBING SET (May 7, 1990)
  • K892856 — NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS (November 8, 1989)
  • K892804 — NEWCHILL(TM) CARDIAC INSULATOR (July 14, 1989)
  • K884055 — SURGI-TAG(TM) STERILE LABEL SETS (October 13, 1988)

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