NVEClass II
Washer, Cleaner, Automated, Endoscope
21 CFR 876.1500 / Gastroenterology, Urology
NVE is the FDA product code for Washer, Cleaner, Automated, Endoscope, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "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...". As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- NVE
- Device name
- Washer, Cleaner, Automated, Endoscope
- 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 endoscopes.
- Regulation
- 21 CFR 876.1500
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 12
- Ingested recalls
- 1
Clearances, product code NVE
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1987 | 2 |
| 1988 | 1 |
| 1998 | 1 |
| 2005 | 1 |
| 2008 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| 2022 | 2 |
Applicants with the most clearances
Product code NVE| Applicant | Clearances |
|---|---|
| STERIS Corporation | 5 |
| American Endoscopy, Inc. | 1 |
| Wassenburg Medical B.V. | 1 |
| Intuitive Surgical, Inc. | 1 |
| Keymed, Inc. | 1 |
| Langford IC Systems, Inc. | 1 |
| Machida America, Inc. | 1 |
| Medivators Inc | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.