Home / 510(k) Clearances / K010637

510(k) K010637

SONOTOME ULTRASONIC ASPIRATOR TIPS by Synergetics, Inc. — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2001
Date Received
March 5, 2001
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 Synergetics, Inc.

  • K160103 — Spetzler Malis Dual Illuminating Bipolar Forceps (October 12, 2016)
  • K143123 — Synergetics PHOTON EX (February 24, 2015)
  • K121426 — AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS (July 10, 2012)
  • K121675 — VERSAVIT (June 21, 2012)
  • K113857 — SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE (April 23, 2012)
  • K110924 — DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS (December 7, 2011)
  • K091441 — SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET (October 30, 2009)
  • K071482 — STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 (December 20, 2007)
  • K063489 — STRYKER INTRADISCAL RF GENERATOR (May 23, 2007)
  • K032598 — SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE (November 24, 2003)

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)