Vapr TC Electrode for Use with Vapr II Electrosurgical System
FDA 510(k) K002402 · Mitek Products
510(k) numberK002402
Submission
- Device name
- Vapr TC Electrode for Use with Vapr II Electrosurgical System
- Applicant
- Mitek Products
Norwood, MA, US - Received
- August 7, 2000
- Decision date
- August 31, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
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| K013572 | Mitek Biocryl Interference ScrewsHWC · Special | 03/14/2002SE |
| K013781 | Rididfix 2.7MM BTB Cross Pin KitHTY · Traditional | 02/06/2002SE |
| K002639 | Bioknotless AnchorGAM · Traditional | 05/11/2001SE |
| K010633 | Rigidfix Soft Tissue Acl Crosspin SystemHWC · Traditional | 05/09/2001SE |
| K002406 | Mitek 2GII Meniscal Repair SystemMAI · Traditional | 02/15/2001SE |
| K003076 | Mitek CufftackMAI · Special | 10/27/2000SE |
| K002422 | Varpr 3.5MM 90 Suction Electrode for Use with Vapr SystemGEI · Special | 08/31/2000SE |
| K000936 | Vapr 2.3MM Wedge Electrode for Use with Vapr SystemGEI · Special | 04/19/2000SE |
| K993575 | Resolve QuickanchorDZL · Traditional | 12/29/1999SE |
| K993327 | Talon Anchor Snap-PakDZL · Traditional | 12/16/1999SE |
Questions and answers
When was Vapr TC Electrode for Use with Vapr II Electrosurgical System cleared by the FDA?
Vapr TC Electrode for Use with Vapr II Electrosurgical System (K002402) received a 510(k) decision of Substantially Equivalent on August 31, 2000, 24 days after the submission was received.
What is the product code of K002402?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.