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510(k) K163188

Next Science Wound Gel (Rx) by Next Science, LLC — Product Code FRO

K163188 is an FDA 510(k) premarket notification submitted by Next Science, LLC for the device "Next Science Wound Gel (Rx)". The FDA issued a decision of Substantially Equivalent on March 6, 2017. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Next Science, LLC has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2017
Date Received
November 14, 2016
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 Next Science, LLC

  • K203446 — TorrentX Wound Wash (September 23, 2021)
  • K203835 — MIS Solution (April 23, 2021)
  • K192349 — Bactisure Wound Lavage (January 23, 2020)
  • K161165 — Next Science Irrigation Solution (September 7, 2016)
  • K150792 — Next Science Wound Gel (December 17, 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