EHL Probe (SCDG-AS) +2 more models
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243032 FDA 510(k)
- FDA Product Code
- FFK FDA 510(k)
- Models / Variants
- EHL Probe (SCDG-AS) FDA 510(k)EHL Probe (SCDG-BS) FDA 510(k)EHL Probe (SCDG-CS) 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 EHL Probe is an electro-hydraulic lithotripter designed to fragment biliary calculi. It functions by delivering high-voltage electrical pulses to the probe tip, which generates hydraulic shock waves within a saline medium to break down stones.
This device is supplied as a sterile, single-use instrument intended for use with the Potent Medical Electrohydraulic Lithotripter. It is designed for compatibility with biliary endoscope access systems and delivery catheters to facilitate procedures in complex anatomical structures. The device has received FDA 510(k) clearance.
Frequently asked questions
What is the primary function of the EHL Probe?
The EHL Probe is designed to fragment biliary calculi. It achieves this by delivering high-voltage electrical pulses to the probe tip, which creates hydraulic shock waves within a saline medium to break down the stones.
Is the EHL Probe intended for reuse?
No, the EHL Probe is a single-use instrument. It is supplied sterile and must be disposed of after a single procedure to maintain patient safety and device integrity.
Which equipment is required to operate this probe?
The EHL Probe is intended for use specifically with the Potent Medical Electrohydraulic Lithotripter. It is also designed to be compatible with biliary endoscope access systems and delivery catheters to allow for navigation within complex anatomical structures.
What regulatory status does this device hold?
The EHL Probe has received FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
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: EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) (K243032 ..., Biliary EHL Probe - Potent Medical, K243032 - EHL Probe (SCDG-AS) - Gastroenterology & Urology, EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) (K243032 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243032 | Class II | Active |
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Manufacturer
Sources (1)
- FDA 510(k) K243032 24 fields · synced Oct 6, 2026