Surgi-Scrub V
FDA 510(k) K822865 · Acme United Corp.
510(k) numberK822865
Submission
- Device name
- Surgi-Scrub V
- Applicant
- Acme United Corp.
Mchenry, IL, US - Received
- September 27, 1982
- Decision date
- October 18, 1982
- 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 |
| K875129 | Steri-ClensGEC · Traditional | Absorbent Cotton Co., Inc. | 02/18/1988SE |
| 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 |
More from K. W. Griffen Co.
| 510(k) | Device | Decision |
|---|---|---|
| K961323 | Lyofoam Extra C Odor Absorbing Wound DressingKMF · Traditional | 06/19/1996SE |
| K961452 | Lyofoam Extra 'A' Sterile Adhesive Wound DressingKMF · Traditional | 05/31/1996SE |
| K952565 | Lyofoam ExtraKMF · Traditional | 11/14/1995SN |
| K895764 | Modified Lyofoam Wound DressingsKMF · Traditional | 09/10/1990SN |
| K871740 | Lyosheet Surgical Sheet for BurnsFPY · Traditional | 06/09/1987SE |
| K864084 | Lyofoam C Odor-Absorbing DressingFRO · Traditional | 11/21/1986SN |
| K860085 | Lyofoam Wound DressingsNAD · Traditional | 06/27/1986SN |
| K860818 | One Time Enteral Feeding BagKNT · Traditional | 05/15/1986SE |
| K861015 | One Time Hyperal & Catheter Dressing Change TraysFOZ · Traditional | 04/22/1986SE |
| K842186 | Acu-Derm Transparent Wound DressingNAD · Traditional | 08/24/1984SE |
Questions and answers
When was Surgi-Scrub V cleared by the FDA?
Surgi-Scrub V (K822865) received a 510(k) decision of Substantially Equivalent on October 18, 1982, 21 days after the submission was received.
What is the product code of K822865?
The FDA product code is GEC – Brush, Scrub, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4800.