Home / 510(k) Clearances / K896085

510(k) K896085

SURGI-BRUSH by Sparta Surgical Corp. — Product Code GEC

K896085 is an FDA 510(k) premarket notification submitted by Sparta Surgical Corp. for the device "SURGI-BRUSH". The FDA issued a decision of Substantially Equivalent on November 8, 1989. The device falls under product code GEC (Brush, Scrub, Operating-Room), a Class I device regulated under 21 CFR 878.4800. Sparta Surgical Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1989
Date Received
October 19, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brush, Scrub, Operating-Room
Device Class
Class I
Regulation Number
878.4800
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)
  • K922729 — SPARTA WET DRESSING, SODIUM CHLORIDE (November 23, 1992)
  • K905384 — DAVID SIMMONDS ANESTHESIA EXTENSION TUBES (March 22, 1991)
  • K905240 — VESSELOOPS (February 6, 1991)
  • K896084 — MICROSPEARS (November 2, 1989)

Other clearances for product code GEC

  • K971473 — IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK (July 7, 1997)
  • K960621 — EXPANDACELL INSTRUMENT WIPE (April 1, 1996)
  • K900691 — BIODYNE INSTRUMENT WIPES (March 8, 1990)
  • K875033 — STERILE SCRUBBY SCRUB BRUSH (February 19, 1988)
  • K875129 — STERI-CLENS (February 18, 1988)
  • K872823 — DELTA SCRUB (January 7, 1988)
  • K874653 — STERILE SURGICAL SCRUB BRUSH (December 30, 1987)
  • K874741 — STERI-CLENS(TM) SURGICAL SCRUB SPONGE (December 10, 1987)
  • K870258 — BIOSCRUB SURGICAL SCRUB BRUSH (February 24, 1987)
  • K854232 — PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES (December 10, 1985)

FDA data resources