Ebi Vuecath Endoscopic Systen
FDA 510(k) K990459 · Electro-Biology, Inc.
510(k) numberK990459
Submission
- Device name
- Ebi Vuecath Endoscopic Systen
- Applicant
- Electro-Biology, Inc.
Parsippany, NJ, US - Received
- February 12, 1999
- Decision date
- April 23, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRX – Arthroscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.1100
- Specialty
- Orthopedic
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code HRX
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|---|---|---|---|
| K260203 | Fule Vertebroplasty Balloon CatheterHRX · Traditional | Beijing Fule Science & Technology Development… | 08/28/2026SE |
| K254103 | HOPKINS Telescopes for ArthroscopyHRX · Traditional | Karl Storz SE & CO. KG | 08/26/2026SE |
| K252790 | Digital ClarusScope System and Digital NeuroPEN SystemHRX · Traditional | Clarus Medical, LLC | 05/26/2026SE |
| K253523 | Freedom DS Decompression SystemHRX · Traditional | Spinal Simplicity | 04/16/2026SE |
| K252546 | VantageTM Lumbar Decompression KitHRX · Traditional | Allevion Medical, LLC | 03/12/2026SE |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500)…HRX · Traditional | Medimaging Integrated Solution, Inc (Miis) | 12/23/2025SE |
| K250795 | Purevue FMSHRX · Traditional | W.O.M. World of Medicine GmbH | 12/05/2025SE |
| K252666 | Articulator Arthroscopic BurHRX · Traditional | Joint Preservation Innovations, LLC | 11/21/2025SE |
| K252458 | Kyphoplasty Balloon Dilatation CathetersHRX · Traditional | Shanghai Lange Medtech Co., Ltd. | 11/03/2025SE |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHRX · Traditional | Hand Biomechanics Lab, Inc. | 10/15/2025SE |
More from Hand Biomechanics Lab, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992333 | Ebi Omega 21 SystemMNI · Traditional | 10/08/1999SE |
| K992367 | Ebi Xfix Dynafix System Ha Coated ScrewsHWC · Traditional | 09/23/1999SE |
| K991941 | Ebi Xfix DFS Rail SystemKTT · Traditional | 08/19/1999SE |
| K991092 | Ebi Spinelink Anterior Cervical Spinal SystemKWQ · Special | 04/29/1999SE |
| K990303 | Ebi Omega 21 SystemKWP · Traditional | 04/29/1999SE |
| K990999 | Modification of: Ebi Spinelink SystemMAI · Special | 04/14/1999SE |
| K984027 | Ebi Spinelink SystemMNI · Traditional | 01/19/1999SE |
| K982484 | Ebi Vuecath Endoscopic Spinal SystemHRX · Traditional | 10/08/1998SE |
| K982908 | Modification to Ebi Spinelink SystemKWP · Special | 08/28/1998SE |
| K981483 | Ebi DFS Joint Fixator, Model 02800KTT · Traditional | 07/08/1998SE |
Questions and answers
When was Ebi Vuecath Endoscopic Systen cleared by the FDA?
Ebi Vuecath Endoscopic Systen (K990459) received a 510(k) decision of Substantially Equivalent on April 23, 1999, 70 days after the submission was received.
What is the product code of K990459?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.