Sterile Scrubby Scrub Brush

FDA 510(k) K875033 · Medsurg Industries, Inc.

Unknown

510(k) numberK875033

Submission

Device name
Sterile Scrubby Scrub Brush
Applicant
Medsurg Industries, Inc.
Herndon, VA, US
Received
December 7, 1987
Decision date
February 19, 1988
Decision
Unknown (SESD)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GEC – Brush, Scrub, Operating-Room
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

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K900691Biodyne Instrument WipesGEC · Traditional Bio-Dyne, Inc.03/08/1990SE
K896085Surgi-BrushGEC · Traditional Sparta Surgical Corp.11/08/1989SE
K875129Steri-ClensGEC · Traditional Absorbent Cotton Co., Inc.02/18/1988SE
K872823Delta ScrubGEC · Traditional Pacific Biosystems, Inc.01/07/1988SE
K874653Sterile Surgical Scrub BrushGEC · Traditional Surgikos, Inc.12/30/1987SE
K874741Steri-Clens(Tm) Surgical Scrub SpongeGEC · Traditional Absorbent Cotton Co., Inc.12/10/1987SE
K870258Bioscrub Surgical Scrub BrushGEC · Traditional K. W. Griffen Co.02/24/1987SE
K854232Pharmaseal Scrub Care-Surgical Scrub Brush SpongesGEC · Traditional American Pharmaseal Div. Ahsc12/10/1985SN

More from American Pharmaseal Div. Ahsc

510(k)DeviceDecision
K920780Medsurg Insertion TrayLFJ · Traditional 08/19/1994SEKD
K940175Medsurg Sterile O.R. TowelsKKX · Traditional 05/26/1994SE
K934731Medsurg Sterile Imaging ProductsFMP · Traditional 03/28/1994SE
K925558InfiltubeHIF · Traditional 03/04/1994SE
K934971Sterile Laparotomy SpongesGDY · Traditional 02/07/1994SE
K920421Medsurg Marshmallow TrayGAT · Traditional 12/13/1993SESK
K920838Medsurg Circumcision TrayHFK · Traditional 10/15/1993SE
K931932Dressing Change Tray-ModifiedMCY · Traditional 08/27/1993SEKD
K914037Medsurg O.R. Procedure TrayLRO · Traditional 06/22/1993SEKD
K914036Medsurg Laparoscopy TrayLRO · Traditional 03/18/1992SE

Questions and answers

When was Sterile Scrubby Scrub Brush cleared by the FDA?

Sterile Scrubby Scrub Brush (K875033) received a 510(k) decision of Unknown on February 19, 1988, 74 days after the submission was received.

What is the product code of K875033?

The FDA product code is GEC – Brush, Scrub, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4800.