Identity
- Trade Name
- LITHOCLAST FDA UDI
- Generic Name
- Ultrasonic lithotripsy system probe, single-use FDA UDI
- Device Name
- Swiss LithoClast Trilogy Disposable Probe kit Ø1.1x625mm FDA UDI
- Model / Reference
- FR-313 FDA UDI
- Description
- Swiss LithoClast Trilogy Disposable Probe kit Ø1.1x625mm FDA UDI
Identifiers
- Catalog Number
- M0068403490 FDA UDI
- Primary DI / UDI-DI
- 07613353123772 FDA UDI
- 510(k) Number
- K173234 FDA UDI
- FDA Product Code
- FFK FDA UDI
- GMDN Term
- Ultrasonic lithotripsy system probe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4480 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 625 Millimeter FDA UDIOuter Diameter — 1.1 Millimeter FDA UDI
Category: Ultrasonic lithotripsy system probe, single-useElectrohydraulic/pneumatic lithotripsy system probe, urinary, single-useIntracorporeal lithotripsy suction system
Lithoclast by E.M.S. Electro Medical Systems S.A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intracorporeal lithotripsy suction system.
- CVAC Aspiration System — Calyxo, Inc. · Class II
- CVAC Aspiration System — Calyxo, Inc. · Class II
- CVAC Aspiration System — Calyxo, Inc. · Class II
- LITHOCLAST — E.M.S. Electro Medical Systems S.A. · Class II
- LITHOCLAST — E.M.S. Electro Medical Systems S.A. · Class II
- LITHOCLAST — E.M.S. Electro Medical Systems S.A. · Class II
- LITHOCLAST — E.M.S. Electro Medical Systems S.A. · Class II
- LITHOCLAST — E.M.S. Electro Medical Systems S.A. · Class II
Cleared under the same submission
K173234 also covers:
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- E.M.S. Electro Medical Systems S.A.
Sources (1)
- FDA UDI 950c57c0-2343-488f-8357-3ce5fbf164e9 37 fields · synced Jun 8, 2026