Bonopty Coaxial Bone Biopsy System with Eccentric Drill(10-1072, 3, 4)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K962425 ↗

FDA Product Code

GAA

Device Class

Class I

Regulation

21 CFR Part 878.4800

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• Femostop, Femostop Pump

  Class II

  FDA 510(k) K954669 Active Cleared 27 Oct 1995

• Radianalyzer, Model 12710, Radiview (Pc-Software Accessory), Model 12720

  Class II

  FDA 510(k) K013943 Active Cleared 18 Dec 2001

• Femostop Femoral Compression System

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• Quantien Measurement System

  Class II

  FDA 510(k) K123984 Active Cleared 28 Mar 2013

• Pressure Wire Sensor .014, Pressure Wire Interface 10, Pressure Wire Monitor Cable

  Class II

  FDA 510(k) K972793 Active Cleared 24 Apr 1998

See all devices from Radi Medical Systems AB →