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 Corporation, Steris and Langford IC Systems, Inc..

12
Total
12
Cleared
136d
Avg days
1983
Since
Stable submission activity - 0 submissions in the last 2 years

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
Cleared Dec 01, 2020
RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector
K203199
STERIS Corporation
General Hospital · 33d
Cleared Apr 03, 2020
RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
K200577
STERIS Corporation
General Hospital · 29d
Cleared Aug 21, 2019
RAS 12 Rack, RAS 12 Long Rack
K190081
STERIS Corporation
General Hospital · 217d
Cleared Aug 01, 2008
DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253
K073112
Intuitive Surgical, Inc.
General Hospital · 270d
Cleared Jun 20, 2005
MANZI CLEANER SYSTEM
K043314
Langford IC Systems, Inc.
General Hospital · 201d
Cleared Sep 22, 1998
MODIFICATION TO SYSTEM 83 PLUS
K983017
Custom Ultrasonics
General Hospital · 25d
Cleared Feb 12, 1987
KEYMED FIBERSCOPE AUTO DISINFECTOR
K861821
Keymed, Inc.
General Hospital · 276d
Cleared Oct 20, 1983
AUTOMATIC ENDOSCOPE
K832458
American Endoscopy, Inc.
General Hospital · 86d

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 remained relatively stable over the observed period, with 0 submissions in the last 24 months.