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FDA 510(k)

PROBET (TM)

K-Number: K903002 · 1991-04-05

ApplicantGynopharma, Inc.
Decision Date1991-04-05
Product CodeHFF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PROBET (TM) is the device name listed in this FDA 510(k) record. The listed applicant is Gynopharma, Inc.. It received FDA 510(k) clearance on 1991-04-05 under 510(k) number K903002. 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 PROBET (TM)?

PROBET (TM) is a medical device that received FDA 510(k) clearance on 1991-04-05. The listed applicant is Gynopharma, Inc.. The 510(k) number is K903002.

When did PROBET (TM) receive FDA 510(k) clearance?

PROBET (TM) received FDA 510(k) clearance on 1991-04-05, under 510(k) number K903002.

Who is the listed applicant for PROBET (TM)?

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

What is the FDA product code for PROBET (TM)?

The FDA product code for PROBET (TM) 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 Gynopharma, 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.

K903001SLIMCATH (TM)

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.

K041237ECHOSAMPLERGynetics Medical Products NVK902693WALLACH 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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