FDA 510(k)

TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6

K-Number: K031951 · 2003-09-11

Decision Date2003-09-11

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6 is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Co., Inc.. It received FDA 510(k) clearance on 2003-09-11 under 510(k) number K031951. 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 TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6?

TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6 is a medical device that received FDA 510(k) clearance on 2003-09-11. The listed applicant is Baylis Medical Co., Inc.. The 510(k) number is K031951.

When did TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6 receive FDA 510(k) clearance?

TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6 received FDA 510(k) clearance on 2003-09-11, under 510(k) number K031951.

Who is the listed applicant for TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6?

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

What is the FDA product code for TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6?

The FDA product code for TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6 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.