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DuoCool Pain Management Probe Model OSP-17-180-20

by Baylis Medical Co., Inc.

510(k) K101372

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 · Special NumberK101372 Date10 Aug 2010ClearedStatusActive

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  • Withdrawn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
GXI
Device Class
Class II
Regulation
21 CFR Part 882.4725
Advisory Committee
Neurology
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 DuoCool Pain Management Probe Model OSP-17-180-20 is a Probe, Radiofrequency Lesion designed for radiofrequency heat lesion procedures. It delivers controlled thermal energy to targeted tissues, aiding in the relief of chronic pain by disrupting nerve pathways or reducing inflammation in specific anatomical regions.

This device is intended for single-use in clinical settings, including neurology, and is classified as a Class II medical device under FDA regulations. It requires sterile packaging and is regulated under the FDA 510(k) clearance (K101372) with a Special clearance type. The probe is not MRI-compatible and must be stored in accordance with manufacturer guidelines to maintain sterility and functionality.

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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 clinical specialties is the DuoCool Pain Management Probe primarily used in, and how does it work?

    The DuoCool Pain Management Probe (Model OSP-17-180-20) is designed for use in neurology settings. It delivers controlled thermal energy via radiofrequency lesioning to targeted tissues, disrupting nerve pathways or reducing inflammation to help manage chronic pain. This procedure is typically performed by neurologists or pain management specialists.

  • Is the DuoCool Pain Management Probe reusable, or is it intended for single-use only?

    The DuoCool Pain Management Probe is explicitly intended for single-use in clinical settings. This design ensures sterility and safety for each patient, reducing the risk of cross-contamination or device degradation between procedures.

  • How should the DuoCool Pain Management Probe be stored to maintain its integrity?

    The probe must be stored in sterile packaging and per the manufacturer’s guidelines to preserve sterility and functionality. Improper storage could compromise its performance or safety for use in radiofrequency lesion procedures.

  • Is the DuoCool Pain Management Probe compatible with MRI machines, or are there any restrictions?

    The DuoCool Pain Management Probe is not MRI-compatible. This means it should never be used or stored near MRI equipment, as exposure to magnetic fields could cause damage or pose safety risks.

  • What regulatory pathway was followed for FDA clearance of this device, and what does that mean for clinicians?

    The DuoCool Pain Management Probe received FDA 510(k) clearance (K101372) under a *Special* clearance type, determined to be *Substantially Equivalent* to a predicate device. This means the FDA reviewed it as a Class II medical device and confirmed it meets safety and effectiveness standards for radiofrequency lesion procedures in neurology, ensuring it adheres to established clinical guidelines.