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FDA 510(k)

United Urologics Intermittent Catheter

K-Number: K160795 · 2016-06-16

ApplicantRobling Medical
Decision Date2016-06-16
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

United Urologics Intermittent Catheter is a medical device manufactured by Robling Medical. It received FDA 510(k) clearance on 2016-06-16 under approval number K160795. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the United Urologics Intermittent Catheter?

United Urologics Intermittent Catheter is a medical device that received FDA 510(k) clearance on 2016-06-16. It is manufactured by Robling Medical. The 510(k) number is K160795.

When was United Urologics Intermittent Catheter approved by the FDA?

United Urologics Intermittent Catheter received FDA 510(k) clearance on 2016-06-16, under approval number K160795.

What company makes United Urologics Intermittent Catheter?

United Urologics Intermittent Catheter is manufactured by Robling Medical.

What is the FDA product code for United Urologics Intermittent Catheter?

The FDA product code for United Urologics Intermittent Catheter is GBM.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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