Shoe Covers
FDA 510(k) K844705 · Medicon, Inc.
510(k) numberK844705
Submission
- Device name
- Shoe Covers
- Applicant
- Medicon, Inc.
Norwalk, CT, US - Received
- December 3, 1984
- Decision date
- January 10, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FXP – Cover, Shoe, Operating-Room
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FXP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971076 | Primed Shoe Covers, Primed Head CoversFXP · Traditional | Primeline Medical Products, Inc. | 01/13/1998SE |
| K971191 | Far-East Shoe CoversFXP · Traditional | Far East Science & Technology Development Co.… | 07/10/1997SE |
| K970815 | Convertors Impervious Shoe CoversFXP · Traditional | Allegiance Healthcare Corp. | 03/27/1997SE |
| K961342 | Shoe Cover, Non-SterileFXP · Traditional | Copioumed Intl., Inc. | 12/30/1996SE |
| K955835 | Fluid Barrier Boot Knee & Ankle-HighFXP · Traditional | Instrument Makar, Inc. | 11/19/1996SE |
| K952937 | Niomed Non-Skid Shoe CoversFXP · Traditional | Amerasia Corp. | 10/23/1995SE |
| K952897 | Niomed Shoe CoversFXP · Traditional | Amerasia Corp. | 10/23/1995SE |
| K943034 | Orex Shoe CoversFXP · Traditional | Thantex Specialties, Inc. | 01/02/1995SE |
| K932738 | Kappler Pro/Vent BootFXP · Traditional | Kappler, Inc. | 03/29/1994SE |
| K925815 | Reusable Liquidproof BootieFXP · Traditional | Amsco Sterile Recoveries, Inc. | 07/09/1993SE |
More from Amsco Sterile Recoveries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K111341 | Cleane / Cleane PopOZC · Traditional | 02/29/2012SE |
| K962087 | Servotronic EC100 SystemHWE · Traditional | 04/23/1997SE |
| K952168 | Titanium Mandibular Fracture SystemJEY · Traditional | 06/22/1995SE |
| K850855 | TENS GB1001 DeviceGZJ · Traditional | 01/09/1986SE |
| K850852 | Infrarax DeviceILY · Traditional | 08/21/1985SE |
| K844702 | Gauze AsorbableEFQ · Traditional | 04/01/1985SE |
| K844573 | Absorbable Gauze ProductsEFQ · Traditional | 03/05/1985SE |
| K844574 | WheelchairsIOR · Traditional | 02/21/1985SE |
| K844704 | Caps (O.R. Nurse, Surgical)FYF · Traditional | 01/10/1985SE |
| K844703 | Gowns, SurgicalFYA · Traditional | 01/10/1985SE |
Questions and answers
When was Shoe Covers cleared by the FDA?
Shoe Covers (K844705) received a 510(k) decision of Substantially Equivalent on January 10, 1985, 38 days after the submission was received.
What is the product code of K844705?
The FDA product code is FXP – Cover, Shoe, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4040.