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FDA 510(k)

ERIS URO-DIAGNOSTIC SYSTEM

K-Number: K850169 · 1985-04-22

ApplicantEris Medical Technology
Decision Date1985-04-22
Product CodeFFG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ERIS URO-DIAGNOSTIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Eris Medical Technology. It received FDA 510(k) clearance on 1985-04-22 under 510(k) number K850169. The device is classified under product code FFG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERIS URO-DIAGNOSTIC SYSTEM?

ERIS URO-DIAGNOSTIC SYSTEM is a medical device that received FDA 510(k) clearance on 1985-04-22. The listed applicant is Eris Medical Technology. The 510(k) number is K850169.

When did ERIS URO-DIAGNOSTIC SYSTEM receive FDA 510(k) clearance?

ERIS URO-DIAGNOSTIC SYSTEM received FDA 510(k) clearance on 1985-04-22, under 510(k) number K850169.

Who is the listed applicant for ERIS URO-DIAGNOSTIC SYSTEM?

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

What is the FDA product code for ERIS URO-DIAGNOSTIC SYSTEM?

The FDA product code for ERIS URO-DIAGNOSTIC SYSTEM is FFG.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Eris Medical Technology 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.

K882295FILLING VOLUME OPTIONK881878CATHETER WITHDRAWAL UNIT

Related Devices (Code: FFG)

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.

K893827PEAK FLOW RATE METERLaytech Medical Co.K883274SURGITEK (R) UROFLOW SYSTEMMedical Engineering Corp.K8443381URO-LOG HOME DIAGNOSTIC PACKEpcom Medical Systems, Inc.K843441URINARY DRAINAGE CONTAINER 2012-WITHVital Metrics, Inc.K843442URINARY DRAINAGE CONTAINER 2013 WITHVital Metrics, Inc.K844030ACCUMETER ELECTRONIC URINEMETER SYSTEMTravenol Laboratories, S.A.

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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