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510(k) K870258

BIOSCRUB SURGICAL SCRUB BRUSH by K. W. Griffen Co. — Product Code GEC

K870258 is an FDA 510(k) premarket notification submitted by K. W. Griffen Co. for the device "BIOSCRUB SURGICAL SCRUB BRUSH". The FDA issued a decision of Substantially Equivalent on February 24, 1987. The device falls under product code GEC (Brush, Scrub, Operating-Room), a Class I device regulated under 21 CFR 878.4800. K. W. Griffen Co. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1987
Date Received
January 23, 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 K. W. Griffen Co.

  • K961098 — BIO-DRESSING, STERILE ISLAND DRESSING (May 3, 1996)
  • K953810 — FLUFF GAUZE BANDAGE, STERILE & NON-STERILE (September 14, 1995)
  • K874161 — MODIFIED USE OF TRIANGLE BANDAGE STERILE (December 4, 1987)

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)
  • K874653 — STERILE SURGICAL SCRUB BRUSH (December 30, 1987)
  • K874741 — STERI-CLENS(TM) SURGICAL SCRUB SPONGE (December 10, 1987)
  • K854232 — PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES (December 10, 1985)

FDA data resources