FDA 510(k)

PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR

K-Number: K113380 · 2012-11-15

Decision Date2012-11-15

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2012-11-15 under 510(k) number K113380. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR?

PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR is a medical device that received FDA 510(k) clearance on 2012-11-15. The listed applicant is Medtronic, Inc.. The 510(k) number is K113380.

When did PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR receive FDA 510(k) clearance?

PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR received FDA 510(k) clearance on 2012-11-15, under 510(k) number K113380.

Who is the listed applicant for PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR?

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

What is the FDA product code for PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR?

The FDA product code for PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR is GEI.

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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.