Custom Ultrasonics, Inc.
Medical device manufacturer in Ivyland, PA.
6510(k) clearances
0PMA approvals
4recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K173590 | System 83 Plus Washer/DisinfectorFEB · Traditional | 03/30/2020SE |
| K162120 | Scope-Assist Flushing SinkFEB · Traditional | 04/28/2017SE |
| K122172 | System 83 PlusFEB · Special | 01/25/2013SE |
| K061430 | System 83 Plus Miniflex Washer-DisinfectorFEB · Traditional | 01/12/2007SE |
| K983017 | Modification to System 83 PlusNVE · Special | 09/22/1998SE |
| K842754 | Custom Ultrasonics-Sys 80, 81-24, 83-2FLG · Traditional | 11/28/1984SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2130-2016 Class II | The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous…To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleaning and/or… | 05/06/2016Terminated |
| Z-0426-2014 Class II | Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully… | 03/12/2013Terminated |
| Z-1182-2008 | System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics…Inadvertent selection of the "wash" cycle | 02/11/2008Terminated |
| Z-0770-2007 | 83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc.The device was marketed without a 510k | 12/12/2005Terminated |