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FDA 510(k)

ACCURETTE

K-Number: K820641 · 1982-06-22

ApplicantAxcan Scientific Corp.
Decision Date1982-06-22
Product CodeHFF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ACCURETTE is the device name listed in this FDA 510(k) record. The listed applicant is Axcan Scientific Corp.. It received FDA 510(k) clearance on 1982-06-22 under 510(k) number K820641. 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 ACCURETTE?

ACCURETTE is a medical device that received FDA 510(k) clearance on 1982-06-22. The listed applicant is Axcan Scientific Corp.. The 510(k) number is K820641.

When did ACCURETTE receive FDA 510(k) clearance?

ACCURETTE received FDA 510(k) clearance on 1982-06-22, under 510(k) number K820641.

Who is the listed applicant for ACCURETTE?

The FDA 510(k) record lists Axcan Scientific Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCURETTE?

The FDA product code for ACCURETTE 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 Axcan Scientific Corp. 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.

K842943AXCAN UTERINE SUCCION INJECTORK831212ENDOSCANNK831224AUGROS HYSTEROMETERK831669AXCAN SPERM CUP

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 NVK903002PROBET (TM)Gynopharma, Inc.K902693WALLACH FLEXIBLE ENDOMETRIAL SAMPLERWallach Surgical Devices, Inc.K831212ENDOSCANNAxcan Scientific Corp.

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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