Autolith 115v
Lithotripter
1manufacturer
1catalogue number
11510(k) clearances naming this product code
6recalls 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 | Northgate Technologies Inc., United States |
|---|---|
| FDA product code | FFK |
| Device type | Lithotriptor, Electro-Hydraulic |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4480 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K923822 |
| Record published | 2016-10-14 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9-201-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lithoclast | E.M.S. Electro Medical Systems S.A. | 73 |
| 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 |
Showing 12 of 73. All products under Lithotriptor, Electro-Hydraulic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202813 | 2021-06-14 |
| K130368 | 2013-11-15 |
| K990341 | 1999-07-14 |
| K944571 | 1995-03-17 |
| K925396 | 1993-07-30 |
| K923822 | 1993-01-28 |
| K914517 | 1992-06-30 |
| K914515 | 1992-01-07 |
| K914516 | 1992-01-07 |
| K914514 | 1992-01-06 |
| K913955 | 1991-11-29 |
Recalls
6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-04-13 | Class II | Under Investigation by firm | Product labeled incorrectly. | 55 probes | 2022-11-08 |
| 2021-10-25 | Class II | Software design (manufacturing process) | The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device. | 2,277 devices | |
| 2020-03-10 | Class II | Nonconforming Material/Component | As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. | 298 boxes. 3 units per box | 2021-02-02 |
| 2020-03-10 | Class II | Nonconforming Material/Component | Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. | 1238 boxes. 3 units per box. | 2021-02-02 |
| 2020-03-10 | Class II | Nonconforming Material/Component | Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. | 198 boxes. 3 units per box. | 2021-02-02 |
| 2017-05-24 | Class II | Labeling mix-ups | The inner and outer labels on the product contain incorrect reference number of 9-202-3751DS. According to Northgate Technologies, the resistor in the probe will not allow the mislabeled product to be used with the incorrect generator. Coul | 186 | 2020-06-09 |
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.