FEB
- Product code
- FEB
- Device name
- Accessories, Cleaning, For Endoscope
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 57 (all years; only the last 3 years are listed here)
FDA classification definition
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).
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K241168 | 2024-12-19 | Wassenburg Medical, Inc. | System 83 Revolve Endoscope Washer/Disinfector | |
| K243433 | 2024-12-02 | STERIS Corporation | enspire 3000 Cleaning and Liquid Chemical Sterilant … |
Official FDA classification page: FEB
Classification and pathway per current FDA publications. Data from openFDA (CC0).