Lithoclast
Swiss LithoClast Trilogy Disposable Probe kit Ø1.1x520mm
1manufacturer
73catalogue numbers in this listing
2510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 4 |
Record
| Listed by | E.M.S. Electro Medical Systems S.A., Switzerland |
|---|---|
| FDA product code | FFK |
| Device type | Lithotriptor, Electro-Hydraulic |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4480 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K173234 |
| Record published | 2018-03-12 |
| Record revised | 2023-10-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment temperature 10 to 30 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 30 to 75 % RH; Storage environment humidity 5 to 85 % RH; Storage environment temperature 5 to 40 °C |
| Packaging | Pack of 5 |
| Sizes | Length 330 to 668 mm; outer diameter 0.8 to 3.9 mm |
| Distribution end date | 2019-01-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B | In distribution | |
| EL-420B | In distribution | |
| FR-312 | Length 520 mm | In distribution |
| FR-364 | In distribution | |
| B | In distribution | |
| EN-057 | In distribution | |
| FR-143 | In distribution | |
| EK-166B | In distribution | |
| B | In distribution | |
| EK-166BR | In distribution | |
| FR-314 | Length 360 mm | In distribution |
| EN-080B | In distribution | |
| EN-057 | In distribution | |
| FR-309 | Length 341 mm | In distribution |
| FR-094 | In distribution | |
| B | In distribution | |
| FR-362R | In distribution | |
| EN-080R | In distribution | |
| FR-307 | Length 340 mm | In distribution |
| B | In distribution | |
| FR-306 | Length 440 mm | In distribution |
| B | In distribution | |
| FT-235US | In distribution | |
| FR-308 | Length 445 mm | In distribution |
| FR-159 | In distribution | |
| EN-057R | In distribution | |
| B | In distribution | |
| B | In distribution | |
| EL-234 | In distribution | |
| FT-235W | In distribution | |
| FR-313 | Length 625 mm | In distribution |
| EL-234 | In distribution | |
| FR-315 | Length 410 mm | In distribution |
| EL-234R | In distribution | |
| FT-235US-MAX | In distribution | |
| FR-362 | In distribution | |
| B | In distribution | |
| EL-419B | In distribution | |
| EL-236R | In distribution | |
| EK-386B | In distribution | |
| FR-296 | Length 340 mm | Withdrawn |
| FR-292 | Length 360 mm | Withdrawn |
| FR-198B | Length 668 mm | Withdrawn |
| FR-083B | Length 403 mm | Withdrawn |
| FR-200B | Length 570 mm | Withdrawn |
| FR-285 | Length 340 mm | Withdrawn |
| FR-293 | Length 410 mm | Withdrawn |
| FR-284 | Length 440 mm | Withdrawn |
| FR-286 | Length 445 mm | Withdrawn |
| FR-199B | Length 453 mm | Withdrawn |
| FT-235R | Withdrawn | |
| FR-295 | Length 440 mm | Withdrawn |
| FR-298 | Length 341 mm | Withdrawn |
| FR-289 | Length 425 mm | Withdrawn |
| FR-287 | Length 341 mm | Withdrawn |
| FR-297 | Length 445 mm | Withdrawn |
| DT-059 | Withdrawn | |
| FR-294 | Length 350 mm | Withdrawn |
| EN-076B | Withdrawn | |
| EK-386BR | Withdrawn | |
| FR-290 | Length 520 mm | Withdrawn |
| FR-106B | Length 330 mm | Withdrawn |
| FR-299 | Length 360 mm | Withdrawn |
| FR-280 | Withdrawn | |
| FR-105B | Length 330 mm | Withdrawn |
| FR-197B | Length 425 mm | Withdrawn |
| FR-084B | Length 403 mm | Withdrawn |
| FR-300 | Length 410 mm | Withdrawn |
| FR-201B | Length 497 mm | Withdrawn |
| FR-310 | Length 350 mm | Withdrawn |
| FR-291 | Length 625 mm | Withdrawn |
| FR-283 | Length 350 mm | Withdrawn |
| FR-288 | Length 350 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Calcusplit | Karl Storz GmbH & Co. KG | 22 |
| Riwolith | Richard Wolf Gmbh | 14 |
| Lithotriptor, Electro-Hydraulic | Karl Storz GmbH & Co. KG | 12 |
| US-Litho | Richard Wolf Gmbh | 11 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 11 |
| Lithotriptor, Electro-Hydraulic | Richard Wolf Gmbh | 9 |
| EHL-Probe | Walz Elektronik Gmbh | 8 |
| Autolith Touch | Northgate Technologies Inc. | 7 |
| StoneBreaker | Cook Incorporated | 7 |
| Swiss LithoClast Select | E.M.S. Electro Medical Systems S.A. | 5 |
| Rigid Pneumatic Probe | Boston Scientific Corporation | 5 |
| Ultrasound Probe | Boston Scientific Corporation | 4 |
Showing 12 of 73. All products under Lithotriptor, Electro-Hydraulic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191124 | 2019-05-29 |
| K123038 | 2013-01-16 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | 510(k) number | 2009-09-17 | Not classified | Other | The label incorrectly reads “compatible with 330mm ultrasound probes (Ref 840-714 and 840-715)” instead of bearing the correct statement “compatible with 403mm ultrasound probes (Ref 840-716 and 840-7170.” | 173 | 2010-10-08 |
| E.M.S. Electro Medical Systems S.A. | 510(k) number | 2005-03-16 | Not classified | Other | Handpiece may become dislodged causing cable damage and possible electric shock. | 160 units | 2016-02-02 |
| E.M.S. Electro Medical Systems S.A. | 510(k) number | 2003-10-03 | Not classified | Other | Failure of foot pedal to activate device | 96 units | 2004-07-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.