Tray, Biopsy, Without Biopsy Instruments
The Biopsy Tray Without Biopsy Instruments (product code FCH) is a sterile procedure tray containing ancillary supplies needed for a biopsy procedure, but excluding the biopsy instruments themselves, providing a convenient setup for the clinician. It is an FDA Class 1 device (lowest risk), subject only to general controls with no premarket notification required. It is regulated under 21 CFR 876.4730 in the Gastroenterology and Urology specialty. No special flags apply.
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Basic Information
- Product Code
- FCH
- Device Class
- FDA class 1
- Regulation Number
- 876.4730
- 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 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.