UroLift System Rigid Retrieval Kit Sterilization Tray— 510(k) K212396

Substantially Equivalent

Neotract, Inc.

FDA 510(k) clearance K212396 for UroLift System Rigid Retrieval Kit Sterilization Tray, Substantially Equivalent on 2021-10-22. Applicant: Neotract, Inc.. Device class: 2.

Clearance details

Applicant
Neotract, Inc.
Product code
Code KCT
Device class
Class 2
Regulation
21 CFR 880.6850
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Pleasanton, CA, US
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