Medihoney Gel Dressing with Active Manuka Honey

• • Ongoing Z-1363-2026 FDA Class II ·initiated 16 Jan 2026

  Potential packaging failures, which could lead to a breach in the sterile barrier.

• • Ongoing Z-1168-2025 FDA Class II ·initiated 10 Jan 2025

  Potential that the induction seal is not completely sealed to the device tube packaging.

• • Ongoing Z-1803-2022 FDA Class III ·initiated 25 May 2022

  Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.

• • Terminated Z-1630-2018 FDA Class II ·initiated 6 Mar 2018

  Incorrect gel part number listed in a master manufacturing record

510(k) Number

K101793 ↗

FDA Product Code

FRO

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Dermagran Hydrophilic Ointment

  Unclassified

  FDA 510(k) K954739 Active Cleared 2 Nov 1995

• Dermagran Wet Dressing (Zinc-Saline)

  Unclassified

  FDA 510(k) K954742 Active Cleared 2 Nov 1995

• Dermagran Wound Dressing

  Unclassified

  FDA 510(k) K924754 Active Cleared 27 May 1993

• Derma Sciences Otc Medihoney Dressings with Active Manuka Honey

  Unclassified

  FDA 510(k) K081584 Active Cleared 19 Jun 2008

• Dermagran Went Dressing (Dextrose-Saline)

  Unclassified

  FDA 510(k) K954741 Active Cleared 1 Nov 1995

• Medihoney Wound Dressings

  Unclassified

  FDA 510(k) K133279 Active Cleared 25 Jun 2015

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