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510(k) K874741

STERI-CLENS(TM) SURGICAL SCRUB SPONGE by Absorbent Cotton Co., Inc. — Product Code GEC

K874741 is an FDA 510(k) premarket notification submitted by Absorbent Cotton Co., Inc. for the device "STERI-CLENS(TM) SURGICAL SCRUB SPONGE". The FDA issued a decision of Substantially Equivalent on December 10, 1987. The device falls under product code GEC (Brush, Scrub, Operating-Room), a Class I device regulated under 21 CFR 878.4800. Absorbent Cotton Co., Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1987
Date Received
November 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 Absorbent Cotton Co., Inc.

  • K883250 — STERI-CLENS WOUND CARE KIT (August 26, 1988)
  • K880613 — ACCO(R) FACE MASK (March 4, 1988)
  • K875129 — STERI-CLENS (February 18, 1988)
  • K873523 — PLAIN DRY GAUZE (October 9, 1987)
  • K854740 — PRIMADERM (March 14, 1986)
  • K850126 — OIL EMULSION NON-ADHERING DRESSING (April 25, 1985)
  • K844095 — WET DRESSING WATER-STERILE (November 27, 1984)
  • K844096 — WET DRESSING SALINE-STERILE (November 19, 1984)
  • K781727 — CHANGE IN STERILIZATION PROCEDURE (December 4, 1978)

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)
  • K870258 — BIOSCRUB SURGICAL SCRUB BRUSH (February 24, 1987)
  • K854232 — PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES (December 10, 1985)

FDA data resources