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510(k) K050776

AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM by Misonix, Inc. — Product Code LFL

K050776 is an FDA 510(k) premarket notification submitted by Misonix, Inc. for the device "AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM". The FDA issued a decision of Substantially Equivalent on June 6, 2005. 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
June 6, 2005
Date Received
March 28, 2005
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 Misonix, Inc.

  • K261448 — neXus Ultrasonic Surgical Aspirator System (July 30, 2026)
  • 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)

Other clearances for product code LFL

  • K261448 — neXus Ultrasonic Surgical Aspirator System (July 30, 2026)
  • 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)

FDA data resources