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Transdiscal System (Transdiscal Probe), Model TDP-17-150-6

by Baylis Medical Co., Inc.

510(k) K031951

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK031951 Date11 Sep 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Transdiscal System (Transdiscal Probe), Model TDP-17-150-6, is an electrosurgical device classified under Electrosurgical, Cutting & Coagulation & Accessories. It is designed for controlled lesioning procedures within the intervertebral disc space, intended to address pain associated with disc pathology. The system combines a probe with an external generator to deliver precise thermal energy, facilitating targeted tissue modification. Its design aligns with previously cleared transdiscal technologies, incorporating refined probe mechanics for enhanced procedural control.

This device is supplied as a reusable system, comprising the Model TDP-17-150-6 probe and a compatible generator. It is intended for use in sterile operating room environments by trained clinicians in spinal pain management procedures. The probe is non-MRI-compatible and must be handled according to manufacturer guidelines to ensure proper sterilisation and functionality. Authorised under FDA 510(k) clearance (K031951), the device adheres to regulatory standards for electrosurgical accessories in general and plastic surgery applications.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of procedures is the Transdiscal System (Model TDP-17-150-6) intended to assist with, and how does it differ from traditional electrosurgical tools?

    The Transdiscal System (Model TDP-17-150-6) is specifically designed for controlled lesioning within the intervertebral disc space to address pain caused by disc pathology. Unlike general electrosurgical tools, it combines a probe with an external generator to deliver targeted thermal energy, enabling precise tissue modification in spinal procedures. This targeted approach distinguishes it from broader electrosurgical devices, which are not designed for intervertebral disc interventions.

  • Is the Transdiscal System reusable, and if so, what sterilization guidelines should be followed?

    Yes, the Transdiscal System is supplied as a reusable system, consisting of the Model TDP-17-150-6 probe and a compatible generator. Since it is intended for sterile operating room use, it must be sterilized according to the manufacturer’s guidelines to ensure proper functionality and safety. The probe is non-MRI-compatible, so additional handling precautions apply.

  • What should clinicians consider when storing or handling the Transdiscal System to maintain its integrity?

    The Transdiscal System must be stored and handled carefully to preserve its functionality, particularly since it is non-MRI-compatible. Clinicians should follow the manufacturer’s instructions for storage, ensuring the probe and generator are kept in a clean, dry environment away from electromagnetic interference. Proper sterilization protocols must also be adhered to before reuse to prevent contamination or damage.

  • How does the regulatory pathway for this device differ from other electrosurgical accessories?

    The Transdiscal System (Model TDP-17-150-6) was cleared through the FDA’s 510(k) pathway under the product code GEI (Electrosurgical, Cutting & Coagulation & Accessories) and was reviewed by the General, Plastic Surgery advisory committee. Unlike some devices cleared under broader classifications, this system was specifically evaluated for its application in spinal pain management, ensuring it meets standards for controlled lesioning within the intervertebral disc space.