Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
The Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia is a Class 2 urology device intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men aged 50 and above. It requires 510(k) clearance and is regulated under 21 CFR 876.5510 within the Gastroenterology and Urology medical specialty. The product code is QKA. The device is not an implant and is not flagged as life-sustaining.
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Basic Information
- Product Code
- QKA
- Device Class
- FDA class 2
- Regulation Number
- 876.5510
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
A system intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.
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 |
|---|---|---|---|---|
| K253525 | Urocross Expander System (Model Numbers ES2018 and ES3025) | Mar 12, 2026 | Substantially Equivalent | Prodeon Medical, Inc. |
| K210138 | iTind System | Jun 25, 2021 | Substantially Equivalent | Medi-Tate , Ltd. |
| DEN190020 | iTind System | Feb 25, 2020 | Unknown | Medi-Tate , Ltd. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.