ShockPulse-SE Lithotripsy System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171024 FDA 510(k)
- FDA Product Code
- FEO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.4480 FDA 510(k)
- Regulation Number
- 876.4480 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ShockPulse-SE Lithotripsy System is a dual action lithotripsy system designed for efficient stone fragmentation. It produces constant ultrasonic wave energy and intermittent shockwave (ballistic/mechanical) energy via a single probe. The device is classified as a Class II medical device under regulation number 876.4480 and is identified by the product code FEO.
The system was granted FDA 510(k) clearance (K171024) on August 21, 2017, following a traditional review process. It is manufactured by Cybersonics, Inc. and is intended for use in gastroenterology and urology settings. The device is supplied as a reusable system and requires appropriate cleaning and maintenance between uses.
Frequently asked questions
What is the ShockPulse-SE Lithotripsy System used for?
The ShockPulse-SE Lithotripsy System is designed for efficient stone fragmentation in urology and gastroenterology settings. It delivers both constant ultrasonic wave energy and intermittent shockwave (ballistic/mechanical) energy through a single probe to break down urinary or biliary stones during procedures.
Is the ShockPulse-SE Lithotripsy System reusable or single-use?
The ShockPulse-SE Lithotripsy System is supplied as a reusable system. It must undergo appropriate cleaning and maintenance between uses to ensure safe and effective operation, as specified by the manufacturer for repeated clinical use.
What type of energy does the ShockPulse-SE Lithotripsy System produce?
The system produces two types of energy: constant ultrasonic wave energy and intermittent shockwave (ballistic/mechanical) energy. Both are delivered via a single probe, enabling dual-action lithotripsy for enhanced stone fragmentation efficiency.
What regulatory pathway was used for the ShockPulse-SE Lithotripsy System?
The ShockPulse-SE Lithotripsy System received FDA 510(k) clearance through a traditional review process. It was found substantially equivalent to predicate devices and cleared under K171024 on August 21, 2017, for use in gastroenterology and urology.
What is the product code and classification for the ShockPulse-SE Lithotripsy System?
The device is identified by the product code FEO and classified as a Class II medical device under regulation number 876.4480. This classification reflects its risk level and regulatory requirements for marketing and use in the United States.
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: ShockPulse-SE | Olympus America | Medical, Olympus Announces Intention to Acquire Lithotripsy Systems from ..., ShockPulse-SE Lithotriptor - Olympus Medical Systems
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171024 | Class II | Active |
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Manufacturer
- Manufacturer
- Cybersonics Inc
- FDA Applicant
- Cybersonics, Inc.
Sources (1)
- FDA 510(k) K171024 24 fields · synced Sep 21, 2026