Rigid Neuroview Endoscope
FDA 510(k) K955037 · Neuro Navigational Corp.
510(k) numberK955037
Submission
- Device name
- Rigid Neuroview Endoscope
- Applicant
- Neuro Navigational Corp.
Costa Mesa, CA, US - Received
- November 3, 1995
- Decision date
- December 4, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K965078 | 2.1MM Semi-Rigid Neuroview SCISSORS/2.0OMM Semi-Rigid Neuroview Grasping ForcepsGWG · Traditional | 03/06/1997SE |
| K961406 | Neuroview ScissorsGWG · Traditional | 06/13/1996SE |
| K961300 | Aspiration/Irrigation CatheterGWG · Traditional | 06/07/1996SE |
| K961173 | 1.2MM Reusable Neuroview EndoscopeGWG · Traditional | 06/07/1996SE |
| K960792 | Disposable Neuroview Introducer SheathGWG · Traditional | 04/11/1996SE |
| K954938 | Disposable Neuroview Operating SheathGWG · Traditional | 03/07/1996SE |
| K955351 | Neuroview Coaxial Bipolar ElectrodeGWG · Traditional | 02/29/1996SE |
| K954899 | Rigid Neuroview EndoscopeGWG · Traditional | 12/19/1995SE |
| K955467 | Neuroview Coaxial Bipolar ElectrodeGEI · Traditional | 12/18/1995SE |
| K952639 | Disposable Toothed Grasping ForcepHRX · Traditional | 09/08/1995SE |
Questions and answers
When was Rigid Neuroview Endoscope cleared by the FDA?
Rigid Neuroview Endoscope (K955037) received a 510(k) decision of Substantially Equivalent for Some Indications on December 4, 1995, 31 days after the submission was received.
What is the product code of K955037?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.