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510(k) K931510

GERITREX STERILE SALINE WET DRESSING by Geritrex Corp. — Product Code FRO

K931510 is an FDA 510(k) premarket notification submitted by Geritrex Corp. for the device "GERITREX STERILE SALINE WET DRESSING". The FDA issued a decision of Substantially Equivalent on July 13, 1993. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Geritrex Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1993
Date Received
March 26, 1993
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 Geritrex Corp.

  • K945224 — GRX FOAM DRESSING (April 3, 1995)
  • K931509 — GERITREX STERILE SALINE SOLUTION FOR IRRIGATION (September 22, 1994)
  • K931511 — GERITREX STERILE WATER FOR IRRIGATION (February 14, 1994)

Other clearances for product code FRO

  • K261646 — Redermax® Antibacterial Wound Matrix (August 14, 2026)
  • K253665 — Vashe Plus Antimicrobial Solution (August 11, 2026)
  • 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)

FDA data resources