Bio-Prep
FDA 510(k) K931846 · Biomedical Devices, Inc.
510(k) numberK931846
Submission
- Device name
- Bio-Prep
- Applicant
- Biomedical Devices, Inc.
Irvine, CA, US - Received
- April 13, 1993
- Decision date
- January 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code LXH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192873 | SX-One MicroKnifeLXH · Traditional | Sonex Health, Inc. | 12/20/2019SE |
| K140414 | Imbibe NeedleLXH · Traditional | Orthovita, Inc. | 04/01/2014SE |
| K101609 | Self Retaining Soft Tissue RetractorLXH · Traditional | Koros USA, Inc. | 12/09/2010SE |
| K001507 | Microperforation InstrumentLXH · Traditional | Smith & Nephew, Inc. | 06/14/2000SE |
| K952495 | Anchors Away Soft Tissue Attachment SystemLXH · Traditional | Orthopedic Systems, Inc. | 01/22/1996SE |
| K943873 | Orthomet Anatomically Guided Carpal Tunnel Release SyLXH · Traditional | Orthomet, Inc. | 04/26/1995SE |
| K944188 | Spinal MarkerLXH · Traditional | Leibinger L.P. | 04/13/1995SE |
| K941896 | Steadman Ligament Graft Passer and ProtectorLXH · Traditional | Depuy, Inc. | 11/07/1994SE |
| K941711 | Hyperflex Flexible GuidewiresLXH · Traditional | Linvatec Corp. | 08/26/1994SE |
| K941605 | Stryker Femoral Canal Brush, Acetabular BrushLXH · Traditional | Stryker Corp. | 08/05/1994SE |
More from Stryker Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K955439 | The Reel Thing (Modification)GBX · Traditional | 12/26/1995SE |
| K931847 | Bio-Prep Cement RestrictorLZN · Traditional | 06/28/1994SE |
| K925982 | BMD Air/Oxygen BlenderBZR · Traditional | 10/07/1993SE |
| K903533 | Steri-ShieldFXY · Traditional | 10/19/1990SE |
| K902677 | Steri-ShieldFXY · Traditional | 08/17/1990SE |
| K830605 | Pump Pall Ambulatory Insulin InfusionFRN · Traditional | 03/31/1983SE |
Questions and answers
When was Bio-Prep cleared by the FDA?
Bio-Prep (K931846) received a 510(k) decision of Substantially Equivalent on January 21, 1994, 283 days after the submission was received.
What is the product code of K931846?
The FDA product code is LXH – Orthopedic Manual Surgical Instrument, a Class I (low risk) device regulated under 21 CFR 888.4540.