Steady Pro
FDA UDIEUDAMEDClass II (US FDA UDI)
by Koelis
Identity
- Trade Name
- Steady Pro support for Full-3D endocavity side-fire probe EUDAMEDSteady Pro FDA UDI
- Generic Name
- Surgical instrument assist arm system, manually-adjusted FDA UDI
- Device Name
- Mechanical articulated arm EUDAMEDProbe holder for transperineal approach. The Steady Pro range is intended to reliably maintain the position of a transrectal ultrasound probe during ultrasound guided interventions. FDA UDI
- Model / Reference
- KSP.SUPP.TP2 EUDAMEDFDA UDISteady Pro EUDAMED
- Description
- Probe holder for transperineal approach. The Steady Pro range is intended to reliably maintain the position of a transrectal ultrasound probe during ultrasound guided interventions. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03665134000912 EUDAMEDFDA UDI
- Basic UDI-DI
- 3665134SteadyPro_01S6 EUDAMED
- Direct Marketing DI
- 03665134000912 EUDAMED
- 510(k) Number
- K171040 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z11049080 VARIOUS ULTRASOUND INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Surgical instrument assist arm system, manually-adjusted FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Surgical instrument assist arm system, manually-adjusted
Steady Pro by Koelis — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical instrument assist arm system, manually-adjusted.
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- ASSISTO® Arm-System — Geomed Medizin-Technik GmbH & Co. KG · Class II
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Koelis
Sources (2)
- FDA UDI 5e2d42eb-6601-4338-8668-c4b3cc90644a 35 fields · synced Jul 10, 2026
- EUDAMED 7da8f34d-411f-451f-b895-8de4612555b3 61 fields · synced Jul 10, 2026