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510(k) K172338

Catasyn Advanced Technology Wound Hydrogel by Synedgen, Inc. — Product Code FRO

K172338 is an FDA 510(k) premarket notification submitted by Synedgen, Inc. for the device "Catasyn Advanced Technology Wound Hydrogel". The FDA issued a decision of Substantially Equivalent on February 21, 2018. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Synedgen, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2018
Date Received
August 2, 2017
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 Synedgen, Inc.

  • K193336 — Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse (May 27, 2020)
  • K143444 — SynePure Wound Cleanser (August 21, 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