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510(k) K874653

STERILE SURGICAL SCRUB BRUSH by Surgikos, Inc. — Product Code GEC

K874653 is an FDA 510(k) premarket notification submitted by Surgikos, Inc. for the device "STERILE SURGICAL SCRUB BRUSH". The FDA issued a decision of Substantially Equivalent on December 30, 1987. The device falls under product code GEC (Brush, Scrub, Operating-Room), a Class I device regulated under 21 CFR 878.4800. Surgikos, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1987
Date Received
November 13, 1987
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 Surgikos, Inc.

  • K875107 — HEALTH CARE EYE PROTECTION (March 21, 1988)
  • K861441 — NEUTRALON SURGICAL GLOVES (May 30, 1986)
  • K852870 — BARRIER SURGICAL GOWN (July 23, 1985)
  • K822535 — CIDEX*DIALYZER DISINFECTING SOLUTION (September 30, 1982)
  • K820543 — BARRIER ANTIMICROBIAL INCISE DRAPE (July 22, 1982)
  • K820542 — SURGIKOS INCISE DRAPE (June 2, 1982)
  • K811871 — BACTERICIDAL INCISE DRAPE (August 20, 1981)
  • K810316 — SURGIKOS FACE MASK (February 23, 1981)
  • K801864 — BARRIER APERTURED DRAPE (August 20, 1980)
  • K801863 — BARRIER TOWEL DRAPE (August 20, 1980)

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)
  • K896085 — SURGI-BRUSH (November 8, 1989)
  • K875033 — STERILE SCRUBBY SCRUB BRUSH (February 19, 1988)
  • K875129 — STERI-CLENS (February 18, 1988)
  • K872823 — DELTA SCRUB (January 7, 1988)
  • 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