Washer, Cleaner, Automated, Endoscope
The Automated Endoscope Washer/Cleaner is a device intended to clean endoscopes through an automated process that includes a chemical dispensing system metering predetermined volumes of detergent during cleaning cycles, with each lumen end positioned in a tray to allow detergent and rinse water to pass through. Endoscopes must be pre-cleaned and leak-tested prior to processing. It is an FDA Class 2 device regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty, reviewed by the General Hospital panel, with product code NVE, requiring 510(k) clearance. It is not an implant and does not carry life-sustaining support designation.
Research product code NVE in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- NVE
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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 endoscopes.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K222849 | 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 | Sep 30, 2022 | Substantially Equivalent | Steris |
| K222543 | 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 | Aug 25, 2022 | Substantially Equivalent | Steris |
| K203199 | RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector | Dec 01, 2020 | Substantially Equivalent | STERIS Corporation |
| K200577 | RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector | Apr 03, 2020 | Substantially Equivalent | STERIS Corporation |
| K190081 | RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector | Aug 21, 2019 | Substantially Equivalent | STERIS Corporation |
| K073112 | DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253 | Aug 01, 2008 | Substantially Equivalent | Intuitive Surgical, Inc. |
| K043314 | MANZI CLEANER SYSTEM | Jun 20, 2005 | Substantially Equivalent | Langford IC Systems, Inc. |
| K983017 | MODIFICATION TO SYSTEM 83 PLUS | Sep 22, 1998 | Substantially Equivalent | Custom Ultrasonics |
| K871712 | MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT. | Jan 14, 1988 | Substantially Equivalent | Machida America, Inc. |
| K861821 | KEYMED FIBERSCOPE AUTO DISINFECTOR | Feb 12, 1987 | Substantially Equivalent | Keymed, Inc. |
| K862402 | OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPES | Feb 03, 1987 | Substantially Equivalent | Medivators, Inc. |
| K832458 | AUTOMATIC ENDOSCOPE | Oct 20, 1983 | Substantially Equivalent | American Endoscopy, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.