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)

FILLING VOLUME OPTION

K-Number: K882295 · 1988-09-13

ApplicantEris Medical Technology
Decision Date1988-09-13
Product CodeLJH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FILLING VOLUME OPTION 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 1988-09-13 under 510(k) number K882295. The device is classified under product code LJH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FILLING VOLUME OPTION?

FILLING VOLUME OPTION is a medical device that received FDA 510(k) clearance on 1988-09-13. The listed applicant is Eris Medical Technology. The 510(k) number is K882295.

When did FILLING VOLUME OPTION receive FDA 510(k) clearance?

FILLING VOLUME OPTION received FDA 510(k) clearance on 1988-09-13, under 510(k) number K882295.

Who is the listed applicant for FILLING VOLUME OPTION?

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 FILLING VOLUME OPTION?

The FDA product code for FILLING VOLUME OPTION is LJH.

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.

K881878CATHETER WITHDRAWAL UNITK850169ERIS URO-DIAGNOSTIC SYSTEM

Related Devices (Code: LJH)

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.

K254111Irrigation/Urology SetsB.Braun Medical, Inc.K162992Karl Storz UROMAT E.A.S.I.Karl Storz Endoscopy America, Inc.K070873AMSURE BLADDER IRRIGATION SETAmsino Intl., Inc.K071832MODIFCATION TO: SPYGLASS IRRIGATION SYSTEMMedical Scientific, Inc.K063700SPYGLASS IRRIGATION SYSTEMMedical Scientific, Inc.K062551NEXUS IRRIGATION TUBING SETNexus Medical, LLC

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.

↑