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510(k) K842024

ULTRASONIC LITHOTRIPTOR 300A by Fibra Sonics, Inc. — Product Code FEO

K842024 is an FDA 510(k) premarket notification submitted by Fibra Sonics, Inc. for the device "ULTRASONIC LITHOTRIPTOR 300A". The FDA issued a decision of Substantially Equivalent on December 11, 1984. The device falls under product code FEO (Lithotriptor, Ultrasonic), a Class II device regulated under 21 CFR 876.4480. Fibra Sonics, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1984
Date Received
May 18, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Ultrasonic
Device Class
Class II
Regulation Number
876.4480
Review Panel
GU
Submission Type

Other clearances by Fibra Sonics, Inc.

  • K993046 — FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 (November 22, 1999)
  • K984199 — EXONIX (February 17, 1999)
  • K984143 — FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM (February 16, 1999)
  • K983199 — FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL (December 14, 1998)
  • K980930 — FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA (September 22, 1998)
  • K834453 — PHACO FRAGMENTOR GT-1 (March 16, 1984)
  • K813389 — ULTRASONIC FRAGMENTOR (February 4, 1982)
  • K812909 — HYGIENTIST; CYCLOSON I & II; RETROFIT (December 14, 1981)
  • K802381 — LEWICKY ANTERIOR CHAMBER MAINTEN. SYS. (December 17, 1980)

Other clearances for product code FEO

  • K230893 — Swiss LthoClast Trilogy (October 23, 2023)
  • K182490 — Swiss LithoClast Trilogy (October 9, 2018)
  • K181997 — Swiss LithoClast Trilogy (August 30, 2018)
  • K181364 — Swiss LithoClast Trilogy (June 20, 2018)
  • K173234 — Swiss LithoClast Trilogy (January 10, 2018)
  • K171024 — ShockPulse-SE Lithotripsy System (August 21, 2017)
  • K142428 — Shock Pulse-SE Lithotripsy System CYBERWAND II (November 13, 2014)
  • K993046 — FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 (November 22, 1999)
  • K973251 — KSEA CALCUSON (June 22, 1998)
  • K920235 — ULTRASOUND GENERATOR MODLE 2270 (December 7, 1992)

FDA data resources