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FDA 510(k)

SHAVER ABLATOR

K-Number: K002088 · 2001-03-06

ApplicantLinvatec Corp.
Decision Date2001-03-06
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SHAVER ABLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 2001-03-06 under 510(k) number K002088. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHAVER ABLATOR?

SHAVER ABLATOR is a medical device that received FDA 510(k) clearance on 2001-03-06. The listed applicant is Linvatec Corp.. The 510(k) number is K002088.

When did SHAVER ABLATOR receive FDA 510(k) clearance?

SHAVER ABLATOR received FDA 510(k) clearance on 2001-03-06, under 510(k) number K002088.

Who is the listed applicant for SHAVER ABLATOR?

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 SHAVER ABLATOR?

The FDA product code for SHAVER ABLATOR is HRX.

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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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