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FDA 510(k)

BAYLIS MEDICAL RF PERFORATION PROBE V2.0

K-Number: K132374 · 2013-08-30

ApplicantBaylis Medical Company, Inc.
Decision Date2013-08-30
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BAYLIS MEDICAL RF PERFORATION PROBE V2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2013-08-30 under 510(k) number K132374. 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 BAYLIS MEDICAL RF PERFORATION PROBE V2.0?

BAYLIS MEDICAL RF PERFORATION PROBE V2.0 is a medical device that received FDA 510(k) clearance on 2013-08-30. The listed applicant is Baylis Medical Company, Inc.. The 510(k) number is K132374.

When did BAYLIS MEDICAL RF PERFORATION PROBE V2.0 receive FDA 510(k) clearance?

BAYLIS MEDICAL RF PERFORATION PROBE V2.0 received FDA 510(k) clearance on 2013-08-30, under 510(k) number K132374.

Who is the listed applicant for BAYLIS MEDICAL RF PERFORATION PROBE V2.0?

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

What is the FDA product code for BAYLIS MEDICAL RF PERFORATION PROBE V2.0?

The FDA product code for BAYLIS MEDICAL RF PERFORATION PROBE V2.0 is GEI.

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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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