Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Robling Medical, Inc.. It received FDA 510(k) clearance on 2016-05-20 under 510(k) 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. The listed applicant is Robling Medical, Inc.. The 510(k) number is K160877.

When did United Urologics Closed System Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for United Urologics Closed System Catheter?

The FDA 510(k) record lists Robling Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Robling Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160795United Urologics Intermittent Catheter

Related Devices (Code: KOD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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.

↑