Home / 510(k) Clearances / K875129

510(k) K875129

STERI-CLENS by Absorbent Cotton Co., Inc. — Product Code GEC

K875129 is an FDA 510(k) premarket notification submitted by Absorbent Cotton Co., Inc. for the device "STERI-CLENS". The FDA issued a decision of Substantially Equivalent on February 18, 1988. 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
February 18, 1988
Date Received
December 15, 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)
  • K874741 — STERI-CLENS(TM) SURGICAL SCRUB SPONGE (December 10, 1987)
  • 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)
  • 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