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)

CLEARVIEW UTERINE MANIPULATOR

K-Number: K940681 · 1994-07-26

ApplicantClinical Innovations, Inc.
Decision Date1994-07-26
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CLEARVIEW UTERINE MANIPULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Innovations, Inc.. It received FDA 510(k) clearance on 1994-07-26 under 510(k) number K940681. 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 CLEARVIEW UTERINE MANIPULATOR?

CLEARVIEW UTERINE MANIPULATOR is a medical device that received FDA 510(k) clearance on 1994-07-26. The listed applicant is Clinical Innovations, Inc.. The 510(k) number is K940681.

When did CLEARVIEW UTERINE MANIPULATOR receive FDA 510(k) clearance?

CLEARVIEW UTERINE MANIPULATOR received FDA 510(k) clearance on 1994-07-26, under 510(k) number K940681.

Who is the listed applicant for CLEARVIEW UTERINE MANIPULATOR?

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

What is the FDA product code for CLEARVIEW UTERINE MANIPULATOR?

The FDA product code for CLEARVIEW UTERINE MANIPULATOR 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 Clinical Innovations, 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.

K030691FETAL SPIRAL ELECTRODE, MODEL FSE07000K022023COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500K003458SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000K981260KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000MK974563COLPO CUP CVC-2000K974389KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER

View all 9 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.

↑