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)

STEERABLE CATHETER SYSTEM

K-Number: K862424 · 1986-09-22

ApplicantEndovations
Decision Date1986-09-22
Product CodeGCP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STEERABLE CATHETER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Endovations. It received FDA 510(k) clearance on 1986-09-22 under 510(k) number K862424. The device is classified under product code GCP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEERABLE CATHETER SYSTEM?

STEERABLE CATHETER SYSTEM is a medical device that received FDA 510(k) clearance on 1986-09-22. The listed applicant is Endovations. The 510(k) number is K862424.

When did STEERABLE CATHETER SYSTEM receive FDA 510(k) clearance?

STEERABLE CATHETER SYSTEM received FDA 510(k) clearance on 1986-09-22, under 510(k) number K862424.

Who is the listed applicant for STEERABLE CATHETER SYSTEM?

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

What is the FDA product code for STEERABLE CATHETER SYSTEM?

The FDA product code for STEERABLE CATHETER SYSTEM is GCP.

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 Endovations 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.

K955413ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETERK942110INJECT-SNAREK934315ENDOVATIONS(R) .035 PRE-CUT PAPILLATOMEK9138412 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATHK9138705MM MICROSCISSORSK911155OVAL CUP BIOPSY FORCEP

View all 37 devices →

Related Devices (Code: GCP)

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.

K954614EOS BRAND DISPOSABLE PROCTOSCOPENorth Eos Industries, Inc.K896505PORGES UNIVERSAL HANDLESPorges Corp.K896008MODEL 6500 MERCURY ARC LIGHT SOURCEMedical Dynamics, Inc.K860103MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVEEndotherapeuticsK843683MODULAR FIBERSCOPE SYSTEMReichert Scientific InstrumentsK833859TAMPONADE BALLOON CUFFAmerican Endoscopy, Inc.

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.

↑