Accessories, Cleaning Brushes, For Endoscope
Accessories and Cleaning Brushes for Endoscopes are devices used to clean and maintain the internal channels and surfaces of endoscopic instruments to ensure proper hygiene and function between procedures. Classified as FDA Class 1 under 21 CFR 876.1500 in the Gastroenterology and Urology specialty, these accessories are 510(k)-exempt and subject only to general controls. The product code is MNL.
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Basic Information
- Product Code
- MNL
- Device Class
- FDA class 1
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K950689 | UCB | Mar 06, 1995 | Substantially Equivalent | Cox Medical Ent., Inc. |
| K946293 | MILL-ROSE SCOPE CLEANING BRUSH | Feb 16, 1995 | Substantially Equivalent | Mill-Rose Laboratory |
| K892218 | ENDO-SPONGE | May 31, 1989 | Substantially Equivalent | Endovations |
| K874239 | CLEANING BRUSH | Dec 29, 1987 | Substantially Equivalent | Endovations |
FEI Numbers
This FDA classification entry is associated with 213 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 213 registration numbers. Click on an entry to view related FDA registrations.