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510(k) K855138

BOVIE ULTRASONIC SURGICAL SYSTEM by Clinical Technology Corp. — Product Code LBK

K855138 is an FDA 510(k) premarket notification submitted by Clinical Technology Corp. for the device "BOVIE ULTRASONIC SURGICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on November 10, 1986. The device falls under product code LBK (Neurosurgical Ultrasonic Instruments), a Class U device. Clinical Technology Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1986
Date Received
December 23, 1985
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 Clinical Technology Corp.

  • K925080 — TEK-LUBE (January 31, 1994)
  • K872867 — BIOSIGN (July 6, 1988)
  • K880166 — BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000 (February 18, 1988)
  • K872705 — BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT) (September 1, 1987)
  • K854231 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCES (May 2, 1986)
  • K853507 — STERI-GRIP (September 5, 1985)
  • K852986 — GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN (August 19, 1985)
  • K844565 — BOVIE X-10 ELECTROSURGICAL GENERATOR(UNIT) (February 21, 1985)
  • K841272 — SICKLE-STAT HEMOGLOBIN S SCREEN KIT (April 13, 1984)
  • K823077 — URINARY BLADDER TEMP. SENSOR #81-003 (March 9, 1983)

Other clearances for product code LBK

  • K972612 — DISSECTRON PORTABLE UNIT (October 8, 1997)
  • K962952 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU) (November 29, 1996)
  • K884413 — CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR (December 2, 1988)
  • K884412 — CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA. (December 2, 1988)
  • K883522 — AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT (September 30, 1988)
  • K853143 — COOPER LASER SONICS CUSA MODEL 200 (October 16, 1985)

FDA data resources