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Microvasive Gold Probe

by Boston Scientific 2 variants

510(k) K970278

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 NumberK970278 Date11 Apr 1997ClearedStatusActive

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  • Withdrawn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
KNS
FDA applicant
Boston Scientific Corp
Device class
Class II
Regulation
21 CFR Part 876.4300
Advisory committee
Gastroenterology, Urology
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 Microvasive Gold Probe is an electrosurgical, endoscopic catheter designed for bipolar coagulation and hemostasis. It delivers precise, uniform energy to control bleeding and achieve tissue sealing, particularly in complex or difficult anatomical positions during endoscopic procedures. Its construction supports en face tangential tamponade, enhancing effectiveness in varied scope orientations.

This device is intended for single-use in gastroenterology and urology settings, supplied sterile and packaged for clinical use. It is classified as Class II under FDA regulations and has received FDA 510(k) clearance (K970278). The probe is non-magnetic and compatible with standard endoscopic equipment, with no specified MRI safety restrictions. Storage requires adherence to manufacturer guidelines for sterile packaging integrity.

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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 is the Microvasive Gold Probe used for?

    The Microvasive Gold Probe is an electrosurgical, endoscopic catheter designed for bipolar coagulation and hemostasis. It delivers precise, uniform energy to control bleeding and achieve tissue sealing, particularly in complex anatomical positions during endoscopic procedures.

  • Is the Microvasive Gold Probe reusable or single-use?

    The Microvasive Gold Probe is intended for single-use in gastroenterology and urology settings. It is supplied sterile and packaged for clinical use, ensuring safety and effectiveness for each procedure.

  • What are the storage requirements for the Microvasive Gold Probe?

    The Microvasive Gold Probe must be stored according to manufacturer guidelines to maintain sterile packaging integrity. Proper storage ensures the device remains safe and effective for clinical use.

  • Is the Microvasive Gold Probe compatible with MRI equipment?

    The Microvasive Gold Probe is non-magnetic and compatible with standard endoscopic equipment. However, there are no specified MRI safety restrictions mentioned in the device data.