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FDA 510(k)

TROCAR SHEATH ANCHOR

K-Number: K915116 · 1992-06-12

ApplicantOrigin Medsystems, Inc.
Decision Date1992-06-12
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TROCAR SHEATH ANCHOR 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 1992-06-12 under 510(k) number K915116. 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 TROCAR SHEATH ANCHOR?

TROCAR SHEATH ANCHOR is a medical device that received FDA 510(k) clearance on 1992-06-12. The listed applicant is Origin Medsystems, Inc.. The 510(k) number is K915116.

When did TROCAR SHEATH ANCHOR receive FDA 510(k) clearance?

TROCAR SHEATH ANCHOR received FDA 510(k) clearance on 1992-06-12, under 510(k) number K915116.

Who is the listed applicant for TROCAR SHEATH ANCHOR?

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 TROCAR SHEATH ANCHOR?

The FDA product code for TROCAR SHEATH ANCHOR 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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