Fluid Pump, CP #3
by United States Endoscopy Group, Inc. 510(k)
Active
510(k) K914524
Overview
The Fluid Pump, CP #3 is an accessory for cleaning endoscopes. It is classified under product code FEB as an accessory for cleaning, for endoscope.
It received FDA 510(k) clearance K914524 on March 9, 1994, following submission on October 10, 1991. The device is classified as Class II with special controls under regulation 876.1500 and was reviewed by the Gastroenterology and Urology advisory committee.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK914524 | Date9 Mar 1994 | 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- Withdrawn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 United States Endoscopy Group, Inc.
Questions
What is the Fluid Pump CP #3 used for?
The Fluid Pump CP #3 is an accessory designed for cleaning endoscopes. It supports the cleaning process by facilitating fluid delivery during reprocessing, as indicated by its classification under product code FEB for accessories for cleaning, for endoscope.
How is the Fluid Pump CP #3 supplied and is it reusable?
The device data does not specify whether the Fluid Pump CP #3 is supplied sterile or non-sterile, or whether it is intended for single-use or reuse. As an accessory for endoscope cleaning, its reusability would depend on the manufacturer's instructions, which are not provided in the available data.
What regulatory pathway was used for the Fluid Pump CP #3?
The Fluid Pump CP #3 received FDA 510(k) clearance under submission K914524, with a decision date of March 9, 1994. It was found substantially equivalent to a predicate device and is classified as Class II with special controls under regulation 876.1500.