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)

IMAGYN INTRAUTERINE INSEMINATION DEVICE

K-Number: K945131 · 1995-05-15

ApplicantImagyn Medical, Inc.
Decision Date1995-05-15
Product CodeHDR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

IMAGYN INTRAUTERINE INSEMINATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Imagyn Medical, Inc.. It received FDA 510(k) clearance on 1995-05-15 under 510(k) number K945131. 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 IMAGYN INTRAUTERINE INSEMINATION DEVICE?

IMAGYN INTRAUTERINE INSEMINATION DEVICE is a medical device that received FDA 510(k) clearance on 1995-05-15. The listed applicant is Imagyn Medical, Inc.. The 510(k) number is K945131.

When did IMAGYN INTRAUTERINE INSEMINATION DEVICE receive FDA 510(k) clearance?

IMAGYN INTRAUTERINE INSEMINATION DEVICE received FDA 510(k) clearance on 1995-05-15, under 510(k) number K945131.

Who is the listed applicant for IMAGYN INTRAUTERINE INSEMINATION DEVICE?

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

What is the FDA product code for IMAGYN INTRAUTERINE INSEMINATION DEVICE?

The FDA product code for IMAGYN INTRAUTERINE INSEMINATION DEVICE 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 Imagyn Medical, 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.

K972426MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATHK970750MICROSPAN INSEMINATION SYSTEMK971255IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCERK965055IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPESK963580IMAGYN FALLOPOSCOPY SYSTEMK961688MICROSPAN HYSTEROSCOPE

View all 19 devices →

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.K950714COOK INSEMINATION CUPCook Urological, Inc.K902171MINISPACE(TM) IUI CATHETERPharmacia, Inc.K902694COAXIAL CATHETER SETCook Ob/Gyn

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.

↑