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FDA 510(k)

AXCAN SPERM CUP

K-Number: K831669 · 1983-07-12

ApplicantAxcan Scientific Corp.
Decision Date1983-07-12
Product CodeHDR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AXCAN SPERM CUP 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 1983-07-12 under 510(k) number K831669. The device is classified under product code HDR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXCAN SPERM CUP?

AXCAN SPERM CUP is a medical device that received FDA 510(k) clearance on 1983-07-12. The listed applicant is Axcan Scientific Corp.. The 510(k) number is K831669.

When did AXCAN SPERM CUP receive FDA 510(k) clearance?

AXCAN SPERM CUP received FDA 510(k) clearance on 1983-07-12, under 510(k) number K831669.

Who is the listed applicant for AXCAN SPERM CUP?

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 AXCAN SPERM CUP?

The FDA product code for AXCAN SPERM CUP is HDR.

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.

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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 HYSTEROMETERK820641ACCURETTE

Related Devices (Code: HDR)

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.

K242031Béa Applicator (BAP-GB-01)Stepone Fertility Ltd (T/A Béa Fertility)K222969FERTI-LILY Conception CupRosesta Medical BVK993953OVES CERVICAL CAPVeos , Ltd.K945131IMAGYN INTRAUTERINE INSEMINATION DEVICEImagyn Medical, Inc.K950714COOK INSEMINATION CUPCook Urological, Inc.K902171MINISPACE(TM) IUI CATHETERPharmacia, Inc.

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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