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FDA 510(k)

DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA

K-Number: K974763 · 1998-07-10

ApplicantDeroyal Industries, Inc.
Decision Date1998-07-10
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 1998-07-10 under 510(k) number K974763. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA?

DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA is a medical device that received FDA 510(k) clearance on 1998-07-10. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K974763.

When did DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA receive FDA 510(k) clearance?

DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA received FDA 510(k) clearance on 1998-07-10, under 510(k) number K974763.

Who is the listed applicant for DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA?

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

What is the FDA product code for DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA?

The FDA product code for DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA is HET.

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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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