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FDA 510(k)

AXCAN UTERINE SUCCION INJECTOR

K-Number: K842943 · 1984-09-21

ApplicantAxcan Scientific Corp.
Decision Date1984-09-21
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AXCAN UTERINE SUCCION INJECTOR 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 1984-09-21 under 510(k) number K842943. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXCAN UTERINE SUCCION INJECTOR?

AXCAN UTERINE SUCCION INJECTOR is a medical device that received FDA 510(k) clearance on 1984-09-21. The listed applicant is Axcan Scientific Corp.. The 510(k) number is K842943.

When did AXCAN UTERINE SUCCION INJECTOR receive FDA 510(k) clearance?

AXCAN UTERINE SUCCION INJECTOR received FDA 510(k) clearance on 1984-09-21, under 510(k) number K842943.

Who is the listed applicant for AXCAN UTERINE SUCCION INJECTOR?

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 UTERINE SUCCION INJECTOR?

The FDA product code for AXCAN UTERINE SUCCION INJECTOR is HIG.

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.

K831212ENDOSCANNK831224AUGROS HYSTEROMETERK831669AXCAN SPERM CUPK820641ACCURETTE

Related Devices (Code: HIG)

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.

K261706Endomat Select (UP220)KARL STORZ SE & CO. KGK251273Asurys Fluid Management SystemBoston Scientific CorporationK240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)Hologic, Inc.K210628X-FLO Fluid Management SystemThermedx, LLCK201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KGK180735Endomat SelectKarl Storz SE & CO. KG

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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