Nucleotome Probe Set, Model 21200
FDA 510(k) K040919 · Clarus Medical, LLC
510(k) numberK040919
Submission
- Device name
- Nucleotome Probe Set, Model 21200
- Applicant
- Clarus Medical, LLC
Minneapolis, MN, US - Received
- April 8, 2004
- Decision date
- June 1, 2004
- 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).
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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 |
|---|---|---|
| K252790 | Digital ClarusScope System and Digital NeuroPEN SystemHRX · Traditional | 05/26/2026SE |
| K240535 | Digital ClarusScope System; Digital NeuroPEN SystemHRX · Traditional | 04/25/2024SE |
| K223615 | Digital ClarusScope System, Digital NeuroPEN SystemGWG · Traditional | 11/21/2023SE |
| K200925 | Clarus Peel-Away Introducer SheathGWG · Traditional | 03/18/2021SE |
| K082038 | Clarus Video Airway Endoscope, Models 30000-V and 30003-VBTR · Traditional | 04/28/2009SE |
| K040424 | Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model…GEX · Traditional | 05/11/2004SE |
| K022610 | Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160GEX · Traditional | 11/05/2002SE |
| K021848 | Clarus Straight Firing Laser Fiber; Clarus Side Firing Laser Fiber; Models 1150, 1160GEX · Traditional | 09/03/2002SE |
| K011454 | Spine Scope, Model 2180HRX · Traditional | 12/13/2001SE |
Questions and answers
When was Nucleotome Probe Set, Model 21200 cleared by the FDA?
Nucleotome Probe Set, Model 21200 (K040919) received a 510(k) decision of Substantially Equivalent on June 1, 2004, 54 days after the submission was received.
What is the product code of K040919?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.