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510(k) K884413

CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR by Valleylab, Inc. — Product Code LBK

K884413 is an FDA 510(k) premarket notification submitted by Valleylab, Inc. for the device "CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR". The FDA issued a decision of Substantially Equivalent on December 2, 1988. The device falls under product code LBK (Neurosurgical Ultrasonic Instruments), a Class U device. Valleylab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1988
Date Received
October 20, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurosurgical Ultrasonic Instruments
Device Class
Class U
Regulation Number
Review Panel
NE
Submission Type

Other clearances by Valleylab, Inc.

  • K092879 — LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER (October 16, 2009)
  • K063195 — LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELECTRODE, MODELS L (November 29, 2006)
  • K053535 — VIVAWAVE MICROWAVE ABLATION SYSTEM (April 27, 2006)
  • K053290 — COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES (March 15, 2006)
  • K052796 — COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES (February 3, 2006)
  • K051644 — VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR (August 11, 2005)
  • K051627 — VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENT (July 22, 2005)
  • K043273 — LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS (January 5, 2005)
  • K042216 — COOL-TIP RF ABLATION SYSTEM (November 12, 2004)
  • K041587 — LIGASURE PRECISE MODEL #LS1200/LIGASURE 5MM LAPAROSCOPIC SEALER DIVIDER MODEL # (September 28, 2004)

Other clearances for product code LBK

  • K972612 — DISSECTRON PORTABLE UNIT (October 8, 1997)
  • K962952 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU) (November 29, 1996)
  • K884412 — CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA. (December 2, 1988)
  • K883522 — AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT (September 30, 1988)
  • K855138 — BOVIE ULTRASONIC SURGICAL SYSTEM (November 10, 1986)
  • K853143 — COOPER LASER SONICS CUSA MODEL 200 (October 16, 1985)

FDA data resources