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Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device

by Medtronic

510(k) K182610

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK182610 Date19 Dec 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
OCL
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Valleylab FT10 Electrosurgical Platform is a Class II surgical device that provides high‑frequency radiofrequency energy for cutting, coagulation, and ablation of tissue, including cardiac tissue. It functions as a generator for monopolar and bipolar procedures and is intended to drive a range of energy‑based instruments in the operating room.

The platform is used with the single‑use Cardioblate BP2 and Cardioblate LP surgical ablation devices, which are bipolar RF ablation tools that incorporate saline irrigation to cool tissue during energy delivery. It is supplied as a reusable generator system for hospital use, received FDA 510(k) clearance (decision date 2018‑12‑19), and is classified under product code OCL for surgical devices.

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Questions

AI-generated answers, 1 Oct 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 can the Valleylab FT10 platform support?

    The FT10 provides high‑frequency radiofrequency energy for cutting, coagulation, and ablation, including both monopolar and bipolar modes. This enables it to be used in general surgical, plastic surgery, and cardiac ablation procedures where precise tissue removal or lesion creation is required.

  • Are the Cardioblate BP2 and LP ablation devices reusable or single‑use?

    Both the Cardioblate BP2 and Cardioblate LP are supplied as single‑use, disposable bipolar RF ablation tools. They incorporate saline irrigation to cool tissue during energy delivery, and each unit is intended for one procedure only to maintain sterility and performance.

  • How is the FT10 system supplied and maintained in a hospital setting?

    The FT10 is provided as a reusable generator system that remains in the operating room for repeated use. It is designed for hospital use, requiring routine cleaning and maintenance according to the manufacturer’s instructions, while the associated ablation handpieces are discarded after each case.

  • What regulatory pathway did the FT10 follow for market entry?

    The device received FDA 510(k) clearance on December 19, 2018, classified as a Class II surgical device under product code OCL. The clearance was based on a determination of substantial equivalence to a predicate device, following the traditional 510(k) submission process.