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510(k) K193085

PuraDERM Gel by 3-D Matrix, Inc. — Product Code FRO

K193085 is an FDA 510(k) premarket notification submitted by 3-D Matrix, Inc. for the device "PuraDERM Gel". The FDA issued a decision of Substantially Equivalent on May 11, 2020. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. 3-D Matrix, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2020
Date Received
November 5, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by 3-D Matrix, Inc.

  • K222481 — PuraStat (February 28, 2023)
  • K213552 — PuraStat-RM (April 1, 2022)
  • K210211 — PuraStat-OM (October 8, 2021)
  • K210098 — PuraStat-GI (June 25, 2021)
  • K183015 — PuraSinus (April 12, 2019)
  • K143058 — PuraDerm Gel (February 13, 2015)

Other clearances for product code FRO

  • K261023 — Microdacyn Wound Irrigation Solution (June 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (June 24, 2026)
  • K261638 — Bonvadis® (June 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (April 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (March 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (March 13, 2026)
  • K252028 — LUOFUCON® Antimicrobial Wound Gel (March 11, 2026)
  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)

FDA data resources