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)

RM3 RENAL PRESERVATION SYSTEM

K-Number: K053169 · 2006-01-17

ApplicantWaters Instruments, Inc.
Decision Date2006-01-17
Product CodeKDK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RM3 RENAL PRESERVATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Waters Instruments, Inc.. It received FDA 510(k) clearance on 2006-01-17 under 510(k) number K053169. The device is classified under product code KDK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RM3 RENAL PRESERVATION SYSTEM?

RM3 RENAL PRESERVATION SYSTEM is a medical device that received FDA 510(k) clearance on 2006-01-17. The listed applicant is Waters Instruments, Inc.. The 510(k) number is K053169.

When did RM3 RENAL PRESERVATION SYSTEM receive FDA 510(k) clearance?

RM3 RENAL PRESERVATION SYSTEM received FDA 510(k) clearance on 2006-01-17, under 510(k) number K053169.

Who is the listed applicant for RM3 RENAL PRESERVATION SYSTEM?

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

What is the FDA product code for RM3 RENAL PRESERVATION SYSTEM?

The FDA product code for RM3 RENAL PRESERVATION SYSTEM is KDK.

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 Waters Instruments, 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.

K042224RM3 RENAL PRESERVATION SYSTEMK971571RM3 RENAL PRESERVATION SYSTEM--CONTROL UNITK921519OXICOM-2100K911207OXICOMPLUSK863210VELCOM-100K862161OSC-80 OXIMETER

View all 12 devices →

Related Devices (Code: KDK)

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.

K911577HYPOTRANS MODEL 750Martin Mclane MedicalK801899KEITHLEY LYMPHOCYTE DEPLETION CARTKeithley Development Co.

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.

↑