Company ยท US
Custom Ultrasonics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2020. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 30, 2020 | K173590 | System 83 Plus Washer/Disinfector Custom Ultrasonics, Inc. | FEB |
| Apr 28, 2017 | K162120 | Scope-Assist Flushing Sink Custom Ultrasonics, Inc. | FEB |
| Jan 25, 2013 | K122172 | SYSTEM 83 PLUS Custom Ultrasonics | FEB |
| Jan 12, 2007 | K061430 | SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR Custom Ultrasonics | FEB |
| Sep 22, 1998 | K983017 | MODIFICATION TO SYSTEM 83 PLUS Custom Ultrasonics | NVE |
| Nov 28, 1984 | K842754 | CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2 Custom Ultrasonics | FLG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2016 | Custom Ultrasonics, Inc. The System 83 Plus, Endoscope Washer/Disinfector
Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts. Terminated |
NVE | None listed |
| Nov 27, 2013 | Custom Ultrasonics, Inc. Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector. Terminated |
KOG | K122172 K983017 |
| Mar 7, 2008 | Custom Ultrasonics, Inc. System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA Terminated |
KOG | K983017 |
| May 4, 2007 | Custom Ultrasonics, Inc. 83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc. Terminated |
FEB | K061430 |