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FDA 510(k)

ENDOPEARL WITH THREADER

K-Number: K993339 · 1999-12-10

ApplicantLinvatec Corp.
Decision Date1999-12-10
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENDOPEARL WITH THREADER is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 1999-12-10 under 510(k) number K993339. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOPEARL WITH THREADER?

ENDOPEARL WITH THREADER is a medical device that received FDA 510(k) clearance on 1999-12-10. The listed applicant is Linvatec Corp.. The 510(k) number is K993339.

When did ENDOPEARL WITH THREADER receive FDA 510(k) clearance?

ENDOPEARL WITH THREADER received FDA 510(k) clearance on 1999-12-10, under 510(k) number K993339.

Who is the listed applicant for ENDOPEARL WITH THREADER?

The FDA 510(k) record lists Linvatec Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOPEARL WITH THREADER?

The FDA product code for ENDOPEARL WITH THREADER is MAI.

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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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