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FDA 510(k)

AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE

K-Number: K912927 · 1991-09-19

ApplicantIntl. Medical, Inc.
Decision Date1991-09-19
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Medical, Inc.. It received FDA 510(k) clearance on 1991-09-19 under 510(k) number K912927. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE?

AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE is a medical device that received FDA 510(k) clearance on 1991-09-19. The listed applicant is Intl. Medical, Inc.. The 510(k) number is K912927.

When did AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE receive FDA 510(k) clearance?

AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE received FDA 510(k) clearance on 1991-09-19, under 510(k) number K912927.

Who is the listed applicant for AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE?

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

What is the FDA product code for AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE?

The FDA product code for AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE is GCJ.

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Related Devices (Code: GCJ)

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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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