Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart E — Surgical Devices](/submissions/GU/subpart-e%E2%80%94surgical-devices) → [21 CFR 876.4480](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4480) → FFK — Lithotriptor, Electro-Hydraulic # FFK · Lithotriptor, Electro-Hydraulic _Gastroenterology, Urology · 21 CFR 876.4480 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK ## Overview - **Product Code:** FFK - **Device Name:** Lithotriptor, Electro-Hydraulic - **Regulation:** [21 CFR 876.4480](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4480) - **Device Class:** 2 - **Review Panel:** [Gastroenterology, Urology](/submissions/GU) - **3rd-party reviewable:** yes ## Identification An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone. ## Classification Rationale Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.” ## Special Controls The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.” ## Recent Cleared Devices (20 of 61) Showing 20 most recent of 61 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K243032](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K243032.md) | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | Mar 21, 2025 | SESE | | [K242888](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K242888.md) | Electrohydraulic Lithotriptor (TCS-B3-II) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | Mar 21, 2025 | SESE | | [K230488](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K230488.md) | EL27-Compact; Sterile EHL-Probes | Walz Elektronik GmbH | Aug 31, 2023 | SESE | | [K202813](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K202813.md) | URO-TOUCH 9 French Probe | Northgate Technologies, Inc. | Jun 14, 2021 | SESE | | [K191124](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K191124.md) | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | May 29, 2019 | SESE | | [K162119](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K162119.md) | UreTron PF Series Probe | Med-Sonics Corp. | Aug 29, 2016 | SESE | | [K160198](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K160198.md) | UreTron MultiProbe Lithotripter System | Med-Sonics Corp. | Feb 23, 2016 | SESE | | [K132795](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K132795.md) | CYBERWAND STERILE PROBE SET | Cybersonics, Inc. | Nov 26, 2013 | SESE | | [K130368](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K130368.md) | AUTOLITH TOUCH; URO TOUCH | Northgate Technologies, Inc. | Nov 15, 2013 | SESE | | [K123038](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K123038.md) | SWISS LITHOBREAKER | E.M.S Electro Medical Systems S.A | Jan 16, 2013 | SESE | | [K120303](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K120303.md) | CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM | Cybersonics, Inc. | Jun 5, 2012 | SESE | | [K111058](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K111058.md) | URETRON MODEL URT | Med-Sonics Corp. | Mar 30, 2012 | SESE | | [K102169](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K102169.md) | CYBERWAND LITHOTRIPTER | Cybersonics, Inc. | Aug 30, 2010 | SESE | | [K092033](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K092033.md) | VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR | Elmed USA | Apr 30, 2010 | SESE | | [K072422](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K072422.md) | CYBERWAND STERILE PADS, MODEL: CW-RBPBX | Cybersonics, Inc. | Oct 24, 2007 | SESE | | [K062475](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K062475.md) | LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM | The Laryngeal Mask Co., Ltd. | May 9, 2007 | SESE | | [K052135](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K052135.md) | CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER | Cybersonics, Inc. | Dec 20, 2005 | SESE | | [K011911](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K011911.md) | SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX | Richard Wolf Medical Instruments Corp. | Sep 17, 2001 | SESE | | [K011848](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K011848.md) | CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE | Circon Video | Sep 11, 2001 | SESE | | [K012445](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK/K012445.md) | EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) | Electro Medical Systems SA | Aug 24, 2001 | SESE | ## Top Applicants - Northgate Technologies, Inc. — 11 clearances - Cybersonics, Inc. — 5 clearances - Northgate Research, Inc. — 5 clearances - Electro Medical Systems SA — 4 clearances - Richard Wolf Medical Instruments Corp. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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