Tube, Drainage, Suprapubic
The Suprapubic Drainage Tube is a urological device placed through the abdominal wall into the bladder to provide an alternative route for urinary drainage, typically used in patients unable to tolerate urethral catheterization. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party 510(k) review. The product code is FFA, regulated under 21 CFR 876.5090, within the Gastroenterology, Urology medical specialty.
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Basic Information
- Product Code
- FFA
- Device Class
- FDA class 2
- Regulation Number
- 876.5090
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K944290 | CATHETERS, BILIARY CATHETERS, UROLOGICAL | Dec 08, 1994 | Substantially Equivalent | Boston Scientific Corp |
| K864770 | SUCTION TUBE | Feb 24, 1987 | Substantially Equivalent | New England Surgical Instrument Corp. |
| K833061 | C-FLEX PENROSE DRAINAGE TUBE | Nov 07, 1983 | Substantially Equivalent | Concept, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.