Da Vinci Sonicpro Cleaning System, Model 400253
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K073112 FDA 510(k)
- FDA Product Code
- NVE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Da Vinci Sonicpro Cleaning System, Model 400253 is an automated washer designed for reusable EndoWrist surgical instruments. It utilizes an ultrasonic tank, fluid pumps, flushing tubing, sensors, and controllers to perform cleaning.
The device is supplied as a floor-standing unit and is intended for use in medical settings. It is a reusable device that requires proper maintenance and storage. The system is cleared by the FDA under 510(k) K073112.
Frequently asked questions
What is the Da Vinci Sonicpro Cleaning System used for?
It is an automated washer designed to clean reusable EndoWrist surgical instruments using ultrasonic technology, fluid pumps, and sensors.
Is the Da Vinci Sonicpro Cleaning System a single-use device?
No, it is a reusable device that requires proper maintenance and storage for continued use.
How is the Da Vinci Sonicpro Cleaning System supplied?
The system is supplied as a floor-standing unit intended for use in medical settings.
What is the regulatory status of the Da Vinci Sonicpro Cleaning System?
The system is cleared by the FDA under 510(k) K073112.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Da Vinci Sonicpro Cleaning System, Model 400253, PDF DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253… - FDA.report, FDA Browser - Cleared 510 (K) - DA VINCI SONICPRO CLEANING SYSTEM ..., PDF Section 11 AUG 1 2008 5 10(k) SUMMARY Nov 02, 2007
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K073112 | Class II | Active |
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Manufacturer
- Manufacturer
- Intuitive Surgical, Inc.
Sources (1)
- FDA 510(k) K073112 24 fields · synced Oct 1, 2026