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510(k) K801623

CAVITRON ULTRASONIC SURG. ASPIR. CUSA by Cavitron Corp. — Product Code LFL

K801623 is an FDA 510(k) premarket notification submitted by Cavitron Corp. for the device "CAVITRON ULTRASONIC SURG. ASPIR. CUSA". The FDA issued a decision of Substantially Equivalent on November 18, 1980. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Cavitron Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1980
Date Received
July 15, 1980
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 Cavitron Corp.

  • K811582 — THE PLACER (July 28, 1981)
  • K810207 — MINOR SURGERY LIGHT (February 13, 1981)
  • K802928 — SPIROMETRIC COMPUTER #SC-10 (December 17, 1980)
  • K801877 — SLIT LAMP ATTACHMENT (September 16, 1980)
  • K800869 — MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA (May 28, 1980)
  • K800722 — AUTO-FIELD D AUTOMATED VISUAL DETECTOR (April 29, 1980)
  • K791585 — MODEL G-61 ULTRASONIC DENTAL UNIT (September 19, 1979)
  • K791277 — MODEL 6500 EXTRACTION IRRIGATION SYS (August 22, 1979)
  • K782054 — LASER, CO2 SURGICAL (January 17, 1979)
  • K782065 — LASER, PHOTOCOAGULATION (December 28, 1978)

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