FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ARTHRO-Pump PA304
K Number: K173311
·
Decision May 9, 2018
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
26
Review Days
203
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ARTHRO-Pump PA304
- K Number
- K173311
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- W.O.M. World of Medicine GmbH
- Date Received
- October 18, 2017
- Decision Date
- May 9, 2018
- Product Code
- HRX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRX), ordered by most recent decision date.
Digital ClarusScope System and Digital NeuroPEN System
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom DS Decompression System
FDA 510(k)
FDA Class 2
·Orthopedic
VantageTM Lumbar Decompression Kit
FDA 510(k)
FDA Class 2
·Orthopedic
MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
FDA 510(k)
FDA Class 2
·Orthopedic
PUREVUE FMS
FDA 510(k)
FDA Class 2
·Orthopedic
Articulator Arthroscopic Bur
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by W.O.M. World of Medicine GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K250795 | PUREVUE FMS | Dec 5, 2025 | Substantially Equivalent |
| K201361 | PNEUMOCLEAR | Jul 29, 2020 | Substantially Equivalent |
| K173489 | GYN-Pump PH304 | Mar 28, 2018 | Substantially Equivalent |
| K172040 | Aquilex Fluid Control System AQL-100S | Feb 5, 2018 | Substantially Equivalent |
| K170784 | PNEUMOCLEAR | May 15, 2017 | Substantially Equivalent |
| K163320 | LAP-Pump PP110 | Mar 21, 2017 | Substantially Equivalent |
| K153513 | Insufflator 50L FM134 | Mar 4, 2016 | Substantially Equivalent |
| K152109 | HD-Camera HDC1000 | Oct 13, 2015 | Substantially Equivalent |
| K011175 | W.O.M. LASER U100 | Nov 1, 2001 | Substantially Equivalent |
| K000153 | ARTHRO-SURGIMAT-A103 | Feb 8, 2000 | Substantially Equivalent |