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510(k) K972612

DISSECTRON PORTABLE UNIT by Satelec — Product Code LBK

K972612 is an FDA 510(k) premarket notification submitted by Satelec for the device "DISSECTRON PORTABLE UNIT". The FDA issued a decision of Substantially Equivalent on October 8, 1997. The device falls under product code LBK (Neurosurgical Ultrasonic Instruments), a Class U device. Satelec has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1997
Date Received
July 14, 1997
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 Satelec

  • K110379 — AIR-N-GO (December 8, 2011)
  • K100410 — PIEZOELECTRIC SYSTEM (April 28, 2010)
  • K091331 — PIEZOTOME 2 (December 11, 2009)
  • K091252 — IMPLANT CENTER 2 (July 22, 2009)
  • K082116 — HEMOSTASYL PASTE (December 17, 2008)
  • K072181 — MINI LED AUTOFOCUS (September 19, 2007)
  • K071965 — I-SURGE (September 10, 2007)
  • K060275 — PIEZOTOME (May 3, 2006)
  • K060274 — PIEZOTOME (May 1, 2006)
  • K053328 — BIOSPLINT SPLINTING RIBBON (January 25, 2006)

Other clearances for product code LBK

  • 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)
  • K855138 — BOVIE ULTRASONIC SURGICAL SYSTEM (November 10, 1986)
  • K853143 — COOPER LASER SONICS CUSA MODEL 200 (October 16, 1985)

FDA data resources