Scope-Assist Flushing Sink
by Custom Ultrasonics, Inc. 510(k)
Active
510(k) K162120
Overview
The Scope-Assist Flushing Sink is an endoscope cleaning accessory designed to mechanically assist the channel flushing portion of the manual cleaning process. It features a large basin to accommodate the bending radius of most flexible endoscopes and provides individual channel adaptation for continuous flushing. The device also includes automatic detergent injection to support the cleaning workflow.
This device is manufactured by Custom Ultrasonics, Inc. and has received FDA 510(k) clearance. It is intended for use in gastroenterology and urology settings as part of the endoscope maintenance process. Users should refer to the operator and maintenance manual for specific instructions regarding its operation and care.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162120 | Date28 Apr 2017 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FEB
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Custom Ultrasonics, Inc.
Questions
What is the primary purpose of the Scope-Assist Flushing Sink?
The Scope-Assist Flushing Sink is designed to mechanically assist the channel flushing portion of the manual endoscope cleaning process. It provides individual channel adaptation for continuous flushing and includes automatic detergent injection to support the cleaning workflow.
Which medical settings is this device intended for?
This device is intended for use in gastroenterology and urology settings as part of the endoscope maintenance process. The basin is specifically sized to accommodate the bending radius of most flexible endoscopes used in these specialties.
What is the regulatory status of the Scope-Assist Flushing Sink?
The Scope-Assist Flushing Sink, manufactured by Custom Ultrasonics, Inc., has received FDA 510(k) clearance under K162120. It is classified as a Class 2 device under regulation number 876.1500.
Where can I find instructions for operating this sink?
Users should refer to the operator and maintenance manual provided by Custom Ultrasonics, Inc. for specific instructions regarding the safe operation and care of the device.