DeviceClearance

Product code PUP— Gastroenterology, Urology

ENDOSCOPE ACCESSORIES, CLEANING, FOR ENDOSCOPE

Classification name
Endoscope Maintenance System
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

FDA classification definition

“To assist in disinfecting, rinsing and storing endoscopes or similar elongated instruments.”

— U.S. Food and Drug Administration, device classification record for product code PUP under 21 CFR 876.1500, via openFDA

Market context for product code PUP

FDA has cleared 1 device under product code PUP, all in 1986, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PUP

Recent clearances under product code PUP

Data sourced from openFDA. This site is unofficial and independent of the FDA.