Ultrasonic Lithotriptor 300A

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K842024 ↗

FDA Product Code

FEO

Device Class

Class II

Regulation

21 CFR Part 876.4480

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Fibra Sonics Ultrasonic Surgical Aspirator System, Model 2100 Ussta

  Unclassified

  FDA 510(k) K980930 Active Cleared 22 Sep 1998

• Fibra Sonics Ultrasonic Lithotriptor Lithosonic, Model Ls-2000

  Class II

  FDA 510(k) K993046 Active Cleared 22 Nov 1999

• Fibra-Sonics Phaco III or Iiip Fragmentation System

  Class II

  FDA 510(k) K984143 Active Cleared 16 Feb 1999

• Phaco Fragmentor Gt-1

  Class II

  FDA 510(k) K834453 Active Cleared 16 Mar 1984

• Lewicky Anterior Chamber Mainten. Sys.

  Class II

  FDA 510(k) K802381 Active Cleared 17 Dec 1980

• Ultrasonic Fragmentor

  Class II

  FDA 510(k) K813389 Active Cleared 4 Feb 1982

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