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FDA 510(k)

GALLINI COAXIAL INTRODUCER

K-Number: K972266 · 1997-07-29

ApplicantGallini U.S., LLC
Decision Date1997-07-29
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GALLINI COAXIAL INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Gallini U.S., LLC. It received FDA 510(k) clearance on 1997-07-29 under 510(k) number K972266. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALLINI COAXIAL INTRODUCER?

GALLINI COAXIAL INTRODUCER is a medical device that received FDA 510(k) clearance on 1997-07-29. The listed applicant is Gallini U.S., LLC. The 510(k) number is K972266.

When did GALLINI COAXIAL INTRODUCER receive FDA 510(k) clearance?

GALLINI COAXIAL INTRODUCER received FDA 510(k) clearance on 1997-07-29, under 510(k) number K972266.

Who is the listed applicant for GALLINI COAXIAL INTRODUCER?

The FDA 510(k) record lists Gallini U.S., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GALLINI COAXIAL INTRODUCER?

The FDA product code for GALLINI COAXIAL INTRODUCER is KNW.

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Other records listing Gallini U.S., LLC 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.

K992499GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLEK990645GALLINI ATRA-CUT NEEDLEK990716GALLINI BYCUT NEEDLEK981301SPEED-CUT AUTOMATIC BIOPSY SYSTEMK980676SPIGAL NEEDLEK980479QUICK-CUT AUTOMATIC BIOPSY SYSTEM

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Related Devices (Code: KNW)

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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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