Endoscope Maintenance System
The Endoscope Maintenance System is a gastroenterology/urology device used to assist in the disinfection, rinsing, and storage of endoscopes or similar elongated instruments, ensuring proper reprocessing between procedures to prevent cross-contamination and healthcare-associated infections. It is classified as FDA Class II under regulation 21 CFR 876.1500, meaning it requires premarket notification (510(k)) clearance and must comply with general and special controls. The product code is PUP and it is reviewed under the General Hospital panel. It is not flagged as an implant or life-sustaining device.
Research product code PUP 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
- PUP
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
Definition
To assist in disinfecting, rinsing and storing endoscopes or similar elongated instruments.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K860246 | ENDOSCOPE ACCESSORIES, CLEANING, FOR ENDOSCOPE | Apr 02, 1986 | Substantially Equivalent | Buckman Co., Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.