Micro-Arthroscope
FDA 510(k) K930084 · Medical Devices, Inc.
510(k) numberK930084
Submission
- Device name
- Micro-Arthroscope
- Applicant
- Medical Devices, Inc.
Hackensack, NJ, US - Received
- January 7, 1993
- Decision date
- September 1, 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).
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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 |
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| K935132 | Home Microcurrent HMCGZJ · Traditional | 03/14/1994SE |
| K934619 | FlexmateGZJ · Traditional | 02/23/1994SE |
| K924897 | Xenon Endoscopic Illuminator, Model XEI-300GCT · Traditional | 07/06/1993SE |
| K930053 | Video Camera W/ Electronic Shutter Model VCE-10FWF · Traditional | 05/17/1993SE |
| K923914 | If-Ii (TM), Model 7200IPF · Traditional | 11/06/1992SE |
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Questions and answers
When was Micro-Arthroscope cleared by the FDA?
Micro-Arthroscope (K930084) received a 510(k) decision of Substantially Equivalent for Some Indications on September 1, 1995, 967 days after the submission was received.
What is the product code of K930084?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.