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FDA 510(k)

PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE

K-Number: K904848 · 1991-04-08

ApplicantOrigin Medsystems, Inc.
Decision Date1991-04-08
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is Origin Medsystems, Inc.. It received FDA 510(k) clearance on 1991-04-08 under 510(k) number K904848. 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 PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE?

PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE is a medical device that received FDA 510(k) clearance on 1991-04-08. The listed applicant is Origin Medsystems, Inc.. The 510(k) number is K904848.

When did PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE receive FDA 510(k) clearance?

PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE received FDA 510(k) clearance on 1991-04-08, under 510(k) number K904848.

Who is the listed applicant for PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE?

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

What is the FDA product code for PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE?

The FDA product code for PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE is HET.

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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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