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510(k) K980097

FLEXIGEL-G HYDROGEL WOUND DRESSING by Innovative Technologies , Ltd. — Product Code MGQ

K980097 is an FDA 510(k) premarket notification submitted by Innovative Technologies , Ltd. for the device "FLEXIGEL-G HYDROGEL WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on March 4, 1998. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), a Class U device. Innovative Technologies , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1998
Date Received
January 12, 1998
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 Innovative Technologies , Ltd.

  • K983303 — INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSING (December 9, 1998)
  • K982234 — AL-GEN CALCIUM ALGINATE DRESSING (September 8, 1998)
  • K982638 — 3M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S 90 (August 21, 1998)
  • K981753 — INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING (June 30, 1998)
  • K980989 — 3M TEGAGEN HI ALGINATE DRESSING & 3M TEGAGEN HG ALGINATE DRESSING (May 27, 1998)
  • K973855 — IT HYDROCOLLOID WITH ZINC (December 1, 1997)
  • K973312 — TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING (October 22, 1997)
  • K973283 — ALGINATE/ZINC WOUND DRESSING (October 21, 1997)
  • K971126 — HYDROCOLLOID WOUND DRESSINGS (June 24, 1997)
  • K963598 — INNOVATIVE TECHNOLOGIES ALIGINATE/PECTIN WOUND DRESSINGS (November 27, 1996)

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