Riza-Ribe Needle (Modification)
FDA 510(k) K954882 · R-Med, Inc.
510(k) numberK954882
Submission
- Device name
- Riza-Ribe Needle (Modification)
- Applicant
- R-Med, Inc.
Oregon, OH, US - Received
- August 10, 1995
- Decision date
- November 16, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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).
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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 |
|---|---|---|
| K001236 | Riza Band Stretcher (RBS)-60000FHN · Traditional | 07/17/2000SE |
| K953360 | R-Med Abdominal Wall ElevatorHET · Traditional | 01/11/1996SE |
| K953441 | Riza-Ribe NeedleFBK · Traditional | 08/18/1995SE |
| K950108 | R-Med Mini-RetractorHET · Traditional | 05/11/1995SE |
| K942411 | R-Med Disposable PlugHET · Traditional | 03/31/1995SE |
| K945637 | R-Med Motorized Laparoscopic HandleGCJ · Traditional | 12/07/1994SE |
| K943818 | Manual Laparosopic Handle, Interchangeable Laparoscopic Tool UnitsGEI · Traditional | 08/29/1994SE |
| K935031 | Riza-Ribe NeedleHET · Traditional | 04/25/1994SE |
Questions and answers
When was Riza-Ribe Needle (Modification) cleared by the FDA?
Riza-Ribe Needle (Modification) (K954882) received a 510(k) decision of Substantially Equivalent on November 16, 1995, 98 days after the submission was received.
What is the product code of K954882?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.