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)

IN-PROBE II URODYNAMIC SYSTEM

K-Number: K983325 · 1998-11-24

ApplicantInfluence, Inc.
Decision Date1998-11-24
Product CodeFEN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IN-PROBE II URODYNAMIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Influence, Inc.. It received FDA 510(k) clearance on 1998-11-24 under 510(k) number K983325. The device is classified under product code FEN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IN-PROBE II URODYNAMIC SYSTEM?

IN-PROBE II URODYNAMIC SYSTEM is a medical device that received FDA 510(k) clearance on 1998-11-24. The listed applicant is Influence, Inc.. The 510(k) number is K983325.

When did IN-PROBE II URODYNAMIC SYSTEM receive FDA 510(k) clearance?

IN-PROBE II URODYNAMIC SYSTEM received FDA 510(k) clearance on 1998-11-24, under 510(k) number K983325.

Who is the listed applicant for IN-PROBE II URODYNAMIC SYSTEM?

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

What is the FDA product code for IN-PROBE II URODYNAMIC SYSTEM?

The FDA product code for IN-PROBE II URODYNAMIC SYSTEM is FEN.

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 Influence, 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.

K981677REPOSE BONE SCREW SYSTEMK991792CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBEK992277STAPLETAC BONE ANCHOR SYSTEMK991122CRYO-MONO CRYOGRNIC SYSTEMK990160MICROTAC-BONE ANCHOR SYSTEMK990095STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM

View all 16 devices →

Related Devices (Code: FEN)

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.

K212830CT3000ProSrs MedicalK082701URONIRS, MODEL 2000Urodynamix Technologies, Ltd.K073552LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORYLaborie Medical Technologies, Corp.K001386ACCUSET SENSOR, MODEL 2000Pelvicare, Inc.K992715NEURO URODYNAMIC SUITE, MODEL 9032E0101Medtronic Functional Diagnostics A/SK970595CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMPCircon Video

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.

↑