NVE · Class II · 21 CFR 876.1500

FDA Product Code NVE: Washer, Cleaner, Automated, Endoscope

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 Endoscopes.

Leading manufacturers include Steris.

12
Total
12
Cleared
136d
Avg days
1983
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Washer, Cleaner, Automated, Endoscope Devices (Product Code NVE)

12 devices
1–12 of 12
Cleared Sep 30, 2022
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector
K222849
Steris
General Hospital · 9d
Cleared Aug 25, 2022
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector
K222543
Steris
General Hospital · 3d

About Product Code NVE - Regulatory Context

510(k) Submission Activity

12 total 510(k) submissions under product code NVE since 1983, with 12 receiving FDA clearance (average review time: 136 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.

NVE devices are reviewed by the General Hospital panel. Browse all General Hospital devices →