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)

INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER

K-Number: K970492 · 1997-04-09

ApplicantAckrad Laboratories
Decision Date1997-04-09
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Ackrad Laboratories. It received FDA 510(k) clearance on 1997-04-09 under 510(k) number K970492. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER?

INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER is a medical device that received FDA 510(k) clearance on 1997-04-09. The listed applicant is Ackrad Laboratories. The 510(k) number is K970492.

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

INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER received FDA 510(k) clearance on 1997-04-09, under 510(k) number K970492.

Who is the listed applicant for INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER?

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

What is the FDA product code for INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER?

The FDA product code for INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER is LKF.

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 Ackrad Laboratories 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.

K021272SIB CATHETER, MODEL 61-7005K020954H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAYK020951H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007K961752H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)K940176ACKRAD IUI SET FOR INTRAUTERINE INSEMINATIONK952542ACKRAD ESOPHAGEAL BALLOON CATHETER SET

View all 42 devices →

Related Devices (Code: LKF)

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.

K253403FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc.K252260RELIEEV HSG Catheter (HSG7FA1)Li Medical Corporation , Ltd.K242002FemVue MINI Saline-Air DeviceFemasys, Inc.K240364RELIEEV Uterine Manipulator Injector (CUMI 5.0)Li Medical Corporation , Ltd.K241693FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc.K222798Rejoni Intrauterine CatheterRejoni, 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.

↑