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510(k) K922729

SPARTA WET DRESSING, SODIUM CHLORIDE by Sparta Surgical Corp. — Product Code FRO

K922729 is an FDA 510(k) premarket notification submitted by Sparta Surgical Corp. for the device "SPARTA WET DRESSING, SODIUM CHLORIDE". The FDA issued a decision of SN on November 23, 1992. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Sparta Surgical Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
November 23, 1992
Date Received
June 5, 1992
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 Sparta Surgical Corp.

  • K965187 — SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD (August 1, 1997)
  • K945313 — SPARTA HYDROGEL WOUND DRESSING (January 12, 1995)
  • K905384 — DAVID SIMMONDS ANESTHESIA EXTENSION TUBES (March 22, 1991)
  • K905240 — VESSELOOPS (February 6, 1991)
  • K896085 — SURGI-BRUSH (November 8, 1989)
  • K896084 — MICROSPEARS (November 2, 1989)

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