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510(k) DEN190020

iTind System by Medi-Tate , Ltd. — Product Code QKA

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
February 25, 2020
Date Received
April 2, 2019
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
Device Class
Class II
Regulation Number
876.5510
Review Panel
GU
Submission Type

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.

Other clearances by Medi-Tate , Ltd.

  • K210138 — iTind System (June 25, 2021)

Other clearances for product code QKA

  • K253525 — Urocross Expander System (Model Numbers ES2018 and ES3025) (March 12, 2026)
  • K210138 — iTind System (June 25, 2021)