ARTHRO-Pump PA304
FDA 510(k) K173311 · W.O.M. World of Medicine GmbH
510(k) numberK173311
Submission
- Device name
- ARTHRO-Pump PA304
- Applicant
- W.O.M. World of Medicine GmbH
Berlin, DE - Received
- October 18, 2017
- Decision date
- May 9, 2018
- 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 |
|---|---|---|
| K250795 | Purevue FMSHRX · Traditional | 12/05/2025SE |
| K201361 | PneumoclearHIF · Traditional | 07/29/2020SE |
| K173489 | GYN-Pump PH304HIG · Traditional | 03/28/2018SE |
| K172040 | Aquilex Fluid Control System AQL-100SHIG · Special | 02/05/2018SE |
| K170784 | PneumoclearHIF · Traditional | 05/15/2017SE |
| K163320 | LAP-Pump PP110HET · Traditional | 03/21/2017SE |
| K153513 | Insufflator 50L FM134HIF · Traditional | 03/04/2016SE |
| K152109 | HD-Camera HDC1000FET · Traditional | 10/13/2015SE |
| K123732 | Hysteroscopy Pump HM6HIG · Special | 04/04/2013SE |
| K112642 | Aquilex Fluid Control System H112HIG · Traditional | 02/06/2012SE |
Questions and answers
When was ARTHRO-Pump PA304 cleared by the FDA?
ARTHRO-Pump PA304 (K173311) received a 510(k) decision of Substantially Equivalent on May 9, 2018, 203 days after the submission was received.
What is the product code of K173311?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.