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FDA 510(k)

United Urologics Closed System Catheter

K-Number: K160877 · 2016-05-20

ApplicantRobling Medical, Inc.
Decision Date2016-05-20
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

United Urologics Closed System Catheter is a medical device manufactured by Robling Medical, Inc.. It received FDA 510(k) clearance on 2016-05-20 under approval number K160877. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the United Urologics Closed System Catheter?

United Urologics Closed System Catheter is a medical device that received FDA 510(k) clearance on 2016-05-20. It is manufactured by Robling Medical, Inc.. The 510(k) number is K160877.

When was United Urologics Closed System Catheter approved by the FDA?

United Urologics Closed System Catheter received FDA 510(k) clearance on 2016-05-20, under approval number K160877.

What company makes United Urologics Closed System Catheter?

United Urologics Closed System Catheter is manufactured by Robling Medical, Inc..

What is the FDA product code for United Urologics Closed System Catheter?

The FDA product code for United Urologics Closed System Catheter is KOD.

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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

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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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