NVE

12 FDA 510(k) clearances · Product code

FDA profile

Official device name

Washer, Cleaner, Automated, Endoscope

Device class

Class II (moderate risk)

Regulation

21 CFR 876.1500

Medical specialty

Gastroenterology, Urology

FDA definition

This automated device is intended to be used to clean endoscopes. Endoscopes that are intended to be cleaned by the automated cleaner system should have been pre-cleaned and tested for leaks and lumen obstructions according to the instrument manufacturer's instructions and current professional practices prior to processing in the system. The system includes a chemical dispensing system that meters out a predetermined volume of detergent during the appropriate cleaning cycle. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). The instrument is placed in a tray with each lumen end positioned in opposite sides of the tray to allow enough detergent and rinsing water pass through the lumens of the

Adverse events (MAUDE)

2008: 20 · 2009: 219 · 2010: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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