Conmed Linvatec 24K Irrigation System
FDA 510(k) K063326 · Conmed Linvatec
510(k) numberK063326
Submission
- Device name
- Conmed Linvatec 24K Irrigation System
- Applicant
- Conmed Linvatec
Largo, FL, US - Received
- November 3, 2006
- Decision date
- January 31, 2007
- 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
| 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 |
|---|---|---|
| K111779 | Y-Knot All-Suture Anchor Model HF13MBI · Traditional | 08/08/2011SE |
| K102410 | Matryx Interference Screw (5.0-6.5MM)HWC · Traditional | 12/21/2010SE |
| K102339 | Conmed Linvatec Sequent Meniscal Repair DeviceGAT · Traditional | 11/23/2010SE |
| K101100 | Crossft Oc Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503MAI · Traditional | 08/26/2010SE |
| K092898 | Conmed Linvatec Presto Preloaded with One or Two #2 Hi-Fi SuturesMAI · Special | 10/19/2009SE |
| K090560 | Conmed Linvatec Anodized Aluminum Sterilization TraysKCT · Abbreviated | 06/29/2009SE |
| K083161 | Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100)HRX · Traditional | 03/27/2009SE |
| K080531 | Conmed Linvatec Microfracture Instrument Sterilization TrayKCT · Traditional | 09/05/2008SE |
| K072291 | Conmed Linvatec Bio Mini-Revo Suture AnchorHWC · Traditional | 07/14/2008SE |
| K080444 | Conmed Linvatec Osprey Drill SystemHBC · Traditional | 04/02/2008SE |
Questions and answers
When was Conmed Linvatec 24K Irrigation System cleared by the FDA?
Conmed Linvatec 24K Irrigation System (K063326) received a 510(k) decision of Substantially Equivalent on January 31, 2007, 89 days after the submission was received.
What is the product code of K063326?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.