Fluid Barrier Boot Knee & Ankle-High
FDA 510(k) K955835 · Instrument Makar, Inc.
510(k) numberK955835
Submission
- Device name
- Fluid Barrier Boot Knee & Ankle-High
- Applicant
- Instrument Makar, Inc.
Okemos, MI, US - Received
- December 26, 1995
- Decision date
- November 19, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K914702 | Sterile View(Tm) Knee-High Boots/Depuy Shoe BootsFXP · Traditional | Depuy, Inc. | 01/29/1993SE |
More from Depuy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K002600 | Litwin Cruicate AnchorMBI · Traditional | 11/15/2000SE |
| K980999 | ST Leger Cemented Semi-Constrained Total Knee ImplantJWH · Traditional | 11/06/1998SE |
| K963396 | Biosphere Suture AnchorMAI · Traditional | 05/06/1997SE |
| K964364 | Disposable ApronLYU · Traditional | 02/25/1997SE |
| K960555 | Bioasbsorbable Mini-Screw Suture AnchorMAI · Traditional | 07/09/1996SE |
| K943249 | Bioabsorbable Interference ScrewMAI · Traditional | 07/31/1995SE |
| K944062 | Laprascopic GrasperGCS · Traditional | 02/23/1995SE |
| K942828 | Makar Full and Half Face ShieldLYU · Traditional | 02/23/1995SE |
| K930980 | Instrument Makar Perfix Interference Bone ScrewHWC · Traditional | 02/10/1994SN |
| K923841 | Bone ScrewsHWC · Traditional | 10/27/1993SE |
Questions and answers
When was Fluid Barrier Boot Knee & Ankle-High cleared by the FDA?
Fluid Barrier Boot Knee & Ankle-High (K955835) received a 510(k) decision of Substantially Equivalent on November 19, 1996, 329 days after the submission was received.
What is the product code of K955835?
The FDA product code is FXP – Cover, Shoe, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4040.