Steri-Clens
FDA 510(k) K875129 · Absorbent Cotton Co., Inc.
510(k) numberK875129
Submission
- Device name
- Steri-Clens
- Applicant
- Absorbent Cotton Co., Inc.
Hammonton, NJ, US - Received
- December 15, 1987
- Decision date
- February 18, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEC – Brush, Scrub, Operating-Room
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971473 | Ivalon Instrument Wipe, Ivalon Knife Cleaning BlockGEC · Traditional | M-Pact Worldwide Management Corp. | 07/07/1997SE |
| K960621 | Expandacell Instrument WipeGEC · Traditional | Shippert Medical Technologies Corp. | 04/01/1996SE |
| K900691 | Biodyne Instrument WipesGEC · Traditional | Bio-Dyne, Inc. | 03/08/1990SE |
| K896085 | Surgi-BrushGEC · Traditional | Sparta Surgical Corp. | 11/08/1989SE |
| K875033 | Sterile Scrubby Scrub BrushGEC · Traditional | Medsurg Industries, Inc. | 02/19/1988SESD |
| K872823 | Delta ScrubGEC · Traditional | Pacific Biosystems, Inc. | 01/07/1988SE |
| K874653 | Sterile Surgical Scrub BrushGEC · Traditional | Surgikos, Inc. | 12/30/1987SE |
| K874741 | Steri-Clens(Tm) Surgical Scrub SpongeGEC · Traditional | Absorbent Cotton Co., Inc. | 12/10/1987SE |
| K870258 | Bioscrub Surgical Scrub BrushGEC · Traditional | K. W. Griffen Co. | 02/24/1987SE |
| K854232 | Pharmaseal Scrub Care-Surgical Scrub Brush SpongesGEC · Traditional | American Pharmaseal Div. Ahsc | 12/10/1985SN |
More from American Pharmaseal Div. Ahsc
| 510(k) | Device | Decision |
|---|---|---|
| K883250 | Steri-Clens Wound Care KitLRO · Traditional | 08/26/1988SE |
| K880613 | Acco(R) Face MaskFXX · Traditional | 03/04/1988SE |
| K874741 | Steri-Clens(Tm) Surgical Scrub SpongeGEC · Traditional | 12/10/1987SE |
| K873523 | Plain Dry GauzeEFQ · Traditional | 10/09/1987SE |
| K854740 | PrimadermNAD · Traditional | 03/14/1986SN |
| K850126 | Oil Emulsion Non-Adhering DressingFRO · Traditional | 04/25/1985SE |
| K844095 | Wet Dressing Water-SterileNAD · Traditional | 11/27/1984SE |
| K844096 | Wet Dressing Saline-SterileFRO · Traditional | 11/19/1984SE |
| K781727 | Change in Sterilization ProcedureGOY · Traditional | 12/04/1978SE |
Questions and answers
When was Steri-Clens cleared by the FDA?
Steri-Clens (K875129) received a 510(k) decision of Substantially Equivalent on February 18, 1988, 65 days after the submission was received.
What is the product code of K875129?
The FDA product code is GEC – Brush, Scrub, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4800.