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FDA 510(k)

TROCAR

K-Number: K914377 · 1991-10-30

ApplicantO.R. Concepts, Inc.
Decision Date1991-10-30
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TROCAR is the device name listed in this FDA 510(k) record. The listed applicant is O.R. Concepts, Inc.. It received FDA 510(k) clearance on 1991-10-30 under 510(k) number K914377. 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 TROCAR?

TROCAR is a medical device that received FDA 510(k) clearance on 1991-10-30. The listed applicant is O.R. Concepts, Inc.. The 510(k) number is K914377.

When did TROCAR receive FDA 510(k) clearance?

TROCAR received FDA 510(k) clearance on 1991-10-30, under 510(k) number K914377.

Who is the listed applicant for TROCAR?

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

What is the FDA product code for TROCAR?

The FDA product code for TROCAR 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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