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510(k) K003824

OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI by Omnisonics Medical Technologies — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2001
Date Received
December 11, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ultrasonic Surgical
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Omnisonics Medical Technologies

  • K083335 — MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM (December 15, 2008)
  • K071762 — OMNIWAVE ENDOVASCULAR SYSTEM (September 27, 2007)
  • K052428 — RESOLUTION ENDOVASCULAR SYSTEM (December 8, 2005)
  • K041705 — RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 (September 1, 2004)
  • K993628 — OMNISONICS ULTRASONIC PROBES (December 15, 1999)
  • K993445 — OMNISONIC ENDOSCOPIC DEFLECTOR (December 6, 1999)
  • K991377 — OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER (July 12, 1999)

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