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QKAClass II

Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

21 CFR 876.5510 / Gastroenterology, Urology
FDA source (opens on fda.gov)

QKA is the FDA product code for Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia, a class II device type, regulated under 21 CFR 876.5510. FDA's definition for this code reads: "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". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QKA
Device name
Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
FDA 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.
Regulation
21 CFR 876.5510
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code QKA

By decision year
4 clearances under product code QKA with a decision year between 2020 and 2026, 2026 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QKA by decision year
YearClearances
20201
20211
20262

Applicants with the most clearances

Product code QKA
Applicants holding the most 510(k) clearances under product code QKA
ApplicantClearances
Medi-Tate2
Prodeon Medical, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code