XKNIFE-4

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

510(k) Number

K981055 ↗

FDA Product Code

IYE

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Radionics Disposable Rf Cannulae (Sc-C, Rfk-Db, Rfk-Ds)

  Class II

  FDA 510(k) K980430 Active Cleared 16 Mar 1998

• Rfg-3CF

  Class II

  FDA 510(k) K965182 Active Cleared 12 Mar 1997

• Radionics Microelectrode Kit

  Class II

  FDA 510(k) K991399 Active Cleared 21 Sep 1999

• Radionics Xdc External Ventricular Catheter

  Class II

  FDA 510(k) K992379 Active Cleared 8 Sep 1999

• Ocular-Biometer 4000

  Class II

  FDA 510(k) K820042 Active Cleared 22 Jul 1982

• Pace-1A Cardiac Stimulator

  Class II

  FDA 510(k) K963579 Active Cleared 8 Nov 1996

See all devices from Radionics, Inc. →

• What is the primary clinical use of the Xknife-4?

  The Xknife-4 is intended for use in stereotactic, collimated beam, computer-planned radiosurgery and radiotherapy treatment within the field of radiology.

• What is the regulatory classification of this device?

  The Xknife-4 is classified as a Class II medical device and has received FDA 510(k) clearance under the regulation number 892.5050.

• Who is the manufacturer of the Xknife-4?

  The Xknife-4 is manufactured by Radionics, Inc., located in Burlington, Massachusetts.