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510(k) K982841

MODIFICATION TO ALLIGER ULTRASONIC SURGICAL SYSTEM, MODEL AUSS-4 by Misonix, Inc. — Product Code LFL

K982841 is an FDA 510(k) premarket notification submitted by Misonix, Inc. for the device "MODIFICATION TO ALLIGER ULTRASONIC SURGICAL SYSTEM, MODEL AUSS-4". The FDA issued a decision of Substantially Equivalent on September 4, 1998. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Misonix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1998
Date Received
August 12, 1998
Clearance Type
Special
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 Misonix, Inc.

  • K221235 — neXus Ultrasonic Surgical Aspirator System (July 28, 2022)
  • K212060 — neXus Ultrasonic Surgical Aspirator System (December 13, 2021)
  • K190160 — neXus Ultrasonic Surgical Aspirator System (May 30, 2019)
  • K123980 — SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES (March 5, 2013)
  • K112782 — MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES (December 1, 2011)
  • K070779 — SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM (July 9, 2008)
  • K070313 — MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM (May 11, 2007)
  • K062471 — ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF (October 26, 2006)
  • K042096 — MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM (January 26, 2006)
  • K052702 — MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY (November 21, 2005)

Other clearances for product code LFL

  • K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System (October 8, 2025)
  • K242894 — SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultr (June 18, 2025)
  • K243930 — Sonopet iQ Ultrasonic Aspirator System (5500-050-000) (March 24, 2025)
  • K241700 — Tenex 2nd Generation System (November 18, 2024)
  • K240493 — CUSA® Clarity Ultrasonic Surgical Aspirator System (July 11, 2024)
  • K233036 — Ultrasonic Surgical System (June 18, 2024)
  • K230427 — CUSA Clarity Ultrasonic Surgical Aspirator System (July 11, 2023)
  • K231117 — neXus Ultrasonic Surgical Aspirator System (June 23, 2023)
  • K221790 — HARMONIC 700 Shears (February 28, 2023)
  • K223770 — Sonopet 1Q 3 7cm 1Q Large (February 16, 2023)

FDA data resources