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FDA 510(k)

ECHOSAMPLER

K-Number: K041237 · 2004-09-08

ApplicantGynetics Medical Products NV
Decision Date2004-09-08
Product CodeHFF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ECHOSAMPLER is the device name listed in this FDA 510(k) record. The listed applicant is Gynetics Medical Products NV. It received FDA 510(k) clearance on 2004-09-08 under 510(k) number K041237. The device is classified under product code HFF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHOSAMPLER?

ECHOSAMPLER is a medical device that received FDA 510(k) clearance on 2004-09-08. The listed applicant is Gynetics Medical Products NV. The 510(k) number is K041237.

When did ECHOSAMPLER receive FDA 510(k) clearance?

ECHOSAMPLER received FDA 510(k) clearance on 2004-09-08, under 510(k) number K041237.

Who is the listed applicant for ECHOSAMPLER?

The FDA 510(k) record lists Gynetics Medical Products NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECHOSAMPLER?

The FDA product code for ECHOSAMPLER is HFF.

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 Gynetics Medical Products NV 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.

K013501IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, BK013536EMTRAC; DELPHIN; SEMTRAC 2000 SETK013497FAS SET #4551

Related Devices (Code: HFF)

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.

K903002PROBET (TM)Gynopharma, Inc.K902693WALLACH FLEXIBLE ENDOMETRIAL SAMPLERWallach Surgical Devices, Inc.K831212ENDOSCANNAxcan Scientific Corp.K820641ACCURETTEAxcan Scientific Corp.

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.

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