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510(k) K962952

OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU) by Olympus Optical, Co. — Product Code LBK

K962952 is an FDA 510(k) premarket notification submitted by Olympus Optical, Co. for the device "OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU)". The FDA issued a decision of Substantially Equivalent on November 29, 1996. The device falls under product code LBK (Neurosurgical Ultrasonic Instruments), a Class U device. Olympus Optical, Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1996
Date Received
July 30, 1996
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 Olympus Optical, Co.

  • K032066 — SONOSURG SYSTEM (October 3, 2003)
  • K030194 — XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT (March 24, 2003)
  • K021962 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (February 12, 2003)
  • K023984 — MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SE (January 31, 2003)
  • K023272 — DISPOSABLE ASPIRATION NEEDLE NA-200H (December 23, 2002)
  • K023767 — UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES (November 29, 2002)
  • K012074 — XBO1-824-18/19/20 BIOPSY FORCEPS (September 25, 2001)
  • K012073 — OLYMPUS SPRAY CATHETER PW-6C-1 (August 10, 2001)
  • K011869 — XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT (July 25, 2001)
  • K011151 — EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z (May 15, 2001)

Other clearances for product code LBK

  • K972612 — DISSECTRON PORTABLE UNIT (October 8, 1997)
  • 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)
  • K855138 — BOVIE ULTRASONIC SURGICAL SYSTEM (November 10, 1986)
  • K853143 — COOPER LASER SONICS CUSA MODEL 200 (October 16, 1985)

FDA data resources