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FDA 510(k)

SHARPE ENDOTENACULUM

K-Number: K915743 · 1993-05-20

ApplicantPaladin Medical, Inc.
Decision Date1993-05-20
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SHARPE ENDOTENACULUM is the device name listed in this FDA 510(k) record. The listed applicant is Paladin Medical, Inc.. It received FDA 510(k) clearance on 1993-05-20 under 510(k) number K915743. 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 SHARPE ENDOTENACULUM?

SHARPE ENDOTENACULUM is a medical device that received FDA 510(k) clearance on 1993-05-20. The listed applicant is Paladin Medical, Inc.. The 510(k) number is K915743.

When did SHARPE ENDOTENACULUM receive FDA 510(k) clearance?

SHARPE ENDOTENACULUM received FDA 510(k) clearance on 1993-05-20, under 510(k) number K915743.

Who is the listed applicant for SHARPE ENDOTENACULUM?

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

What is the FDA product code for SHARPE ENDOTENACULUM?

The FDA product code for SHARPE ENDOTENACULUM 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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