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FDA 510(k)

INTRAUTERINE CATHETER

K-Number: K861305 · 1986-12-11

ApplicantRam Development
Decision Date1986-12-11
Product CodeHDR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INTRAUTERINE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Ram Development. It received FDA 510(k) clearance on 1986-12-11 under 510(k) number K861305. The device is classified under product code HDR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRAUTERINE CATHETER?

INTRAUTERINE CATHETER is a medical device that received FDA 510(k) clearance on 1986-12-11. The listed applicant is Ram Development. The 510(k) number is K861305.

When did INTRAUTERINE CATHETER receive FDA 510(k) clearance?

INTRAUTERINE CATHETER received FDA 510(k) clearance on 1986-12-11, under 510(k) number K861305.

Who is the listed applicant for INTRAUTERINE CATHETER?

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

What is the FDA product code for INTRAUTERINE CATHETER?

The FDA product code for INTRAUTERINE CATHETER is HDR.

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 Ram Development 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.

K862691STOPCOCK

Related Devices (Code: HDR)

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.

K242031Béa Applicator (BAP-GB-01)Stepone Fertility Ltd (T/A Béa Fertility)K222969FERTI-LILY Conception CupRosesta Medical BVK993953OVES CERVICAL CAPVeos , Ltd.K945131IMAGYN INTRAUTERINE INSEMINATION DEVICEImagyn Medical, Inc.K950714COOK INSEMINATION CUPCook Urological, Inc.K902171MINISPACE(TM) IUI CATHETERPharmacia, 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.

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