Cleaners, Medical Devices
Medical device cleaners are general hospital devices used to remove biological and chemical contaminants from reusable medical instruments and equipment surfaces as part of the reprocessing workflow prior to disinfection or sterilization. They are classified as FDA Class II under 21 CFR 880.6992 within the General Hospital specialty, requiring 510(k) premarket clearance. The product code is MDZ and the devices are not implanted. Full GMP quality system requirements apply.
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Basic Information
- Product Code
- MDZ
- Device Class
- FDA class 2
- Regulation Number
- 880.6992
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.