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510(k) K190060

Urethrotech UCD by Urethrotech — Product Code EZL

K190060 is an FDA 510(k) premarket notification submitted by Urethrotech for the device "Urethrotech UCD". The FDA issued a decision of Substantially Equivalent on October 4, 2019. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2019
Date Received
January 11, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type, Balloon
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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  • K212077 — Teleflex Rusch SoftSimplastic Foley Catheters (July 27, 2023)
  • K231101 — Flume Catheter (June 29, 2023)
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FDA data resources