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FDA 510(k)

INSEMINATION CATHETER, MODEL 320301

K-Number: K021438 · 2002-07-16

ApplicantLabotect Labor-Technik Gottingen
Decision Date2002-07-16
Product CodeMFD
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INSEMINATION CATHETER, MODEL 320301 is the device name listed in this FDA 510(k) record. The listed applicant is Labotect Labor-Technik Gottingen. It received FDA 510(k) clearance on 2002-07-16 under 510(k) number K021438. 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 INSEMINATION CATHETER, MODEL 320301?

INSEMINATION CATHETER, MODEL 320301 is a medical device that received FDA 510(k) clearance on 2002-07-16. The listed applicant is Labotect Labor-Technik Gottingen. The 510(k) number is K021438.

When did INSEMINATION CATHETER, MODEL 320301 receive FDA 510(k) clearance?

INSEMINATION CATHETER, MODEL 320301 received FDA 510(k) clearance on 2002-07-16, under 510(k) number K021438.

Who is the listed applicant for INSEMINATION CATHETER, MODEL 320301?

The FDA 510(k) record lists Labotect Labor-Technik Gottingen as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INSEMINATION CATHETER, MODEL 320301?

The FDA product code for INSEMINATION CATHETER, MODEL 320301 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 Labotect Labor-Technik Gottingen 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.

K003056OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218K000950EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201

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.

K012935THECURVE, 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 PlcK972823MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETERA & A Medical, Inc.

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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