Home / 510(k) Clearances / K183662

510(k) K183662

Saline Wound Wash, SteriCleanse(TM) by Ascent Consumer Products, Inc. — Product Code FRO

K183662 is an FDA 510(k) premarket notification submitted by Ascent Consumer Products, Inc. for the device "Saline Wound Wash, SteriCleanse(TM)". The FDA issued a decision of Substantially Equivalent on September 12, 2019. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2019
Date Received
December 27, 2018
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 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