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FDA 510(k)

SELECT IUI

K-Number: K954099 · 1995-11-22

ApplicantSelect Medical Systems, Inc.
Decision Date1995-11-22
Product CodeMFD
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SELECT IUI is the device name listed in this FDA 510(k) record. The listed applicant is Select Medical Systems, Inc.. It received FDA 510(k) clearance on 1995-11-22 under 510(k) number K954099. The device is classified under product code MFD. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELECT IUI?

SELECT IUI is a medical device that received FDA 510(k) clearance on 1995-11-22. The listed applicant is Select Medical Systems, Inc.. The 510(k) number is K954099.

When did SELECT IUI receive FDA 510(k) clearance?

SELECT IUI received FDA 510(k) clearance on 1995-11-22, under 510(k) number K954099.

Who is the listed applicant for SELECT IUI?

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

What is the FDA product code for SELECT IUI?

The FDA product code for SELECT IUI is MFD.

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 Select Medical Systems, 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.

K012935THECURVE, ITEM 507K974819SELECTCELLS(TM) MINIK954102SELECTMUCUSK954097SELECTCELLS STANDARDK942922SELECTA 20/60 CHEMISTRY ANALYZER

Related Devices (Code: MFD)

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.

K021438INSEMINATION CATHETER, MODEL 320301Labotect Labor-Technik GottingenK012935THECURVE, ITEM 507Select Medical Systems, Inc.K984306`THE INSEMINATOR' (PROPOSED)Wallach Surgical Devices, Inc.K982630MEDWORKS VISUALIZATION INSEMINATION CATHETERMedworks Corp.K982628MEDWORKS INSEMINATION CATHETERMedworks Corp.K980061EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTERRocket Medical Plc

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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