Instrument, Catheter, Punch
The Catheter Punch Instrument is a manual surgical tool used during catheter-related urological procedures to create or modify access openings. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket notification requirement. The product code is FEX, regulated under 21 CFR 876.5090, within the Gastroenterology, Urology medical specialty.
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Basic Information
- Product Code
- FEX
- Device Class
- FDA class 1
- Regulation Number
- 876.5090
- 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 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.