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510(k) K962851

ACRYNOODLES ABSORBENT WOUND DRESSING by Acrymed, Inc. — Product Code MGQ

K962851 is an FDA 510(k) premarket notification submitted by Acrymed, Inc. for the device "ACRYNOODLES ABSORBENT WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on September 6, 1996. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), a Class U device. Acrymed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1996
Date Received
July 22, 1996
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 Acrymed, Inc.

  • K091354 — ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING (October 21, 2009)
  • K083103 — ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B (February 26, 2009)
  • K082459 — ACRYDERM ABSORBENT OXYGEN DRESSING (September 19, 2008)
  • K070333 — ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL (July 10, 2007)
  • K061232 — ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006 (October 6, 2006)
  • K011994 — ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101 (November 8, 2001)
  • K012116 — ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING (September 12, 2001)
  • K002909 — ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103 (October 13, 2000)
  • K002599 — MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, (September 21, 2000)
  • K991818 — ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 10 (April 17, 2000)

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