Extender Cable, Autolith Touch
Extender cable for use with Autolith Touch Lithotripter, BSC
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) | K130368 |
| Record published | 2017-02-09 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M00546750 | 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 Naming This Product
4 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 |
|---|---|---|---|---|---|---|---|
| Northgate Technologies Inc. | 510(k) number | 2022-04-13 | Class II | Under Investigation by firm | Product labeled incorrectly. | 55 probes | 2022-11-08 |
| Northgate Technologies Inc. | 510(k) number | 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 | |
| Northgate Technologies Inc. | 510(k) number | 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 |
| Northgate Technologies Inc. | 510(k) number | 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 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 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 |
| 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.