Custom Ultrasonics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2130-2016 | Class II | The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up t | May 6, 2016 |
| Z-0426-2014 | Class II | Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector. | March 12, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K173590 | System 83 Plus Washer/Disinfector | March 30, 2020 |
| K162120 | Scope-Assist Flushing Sink | April 28, 2017 |
| K122172 | SYSTEM 83 PLUS | January 25, 2013 |
| K061430 | SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR | January 12, 2007 |
| K983017 | MODIFICATION TO SYSTEM 83 PLUS | September 22, 1998 |
| K842754 | CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2 | November 28, 1984 |