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510(k) K884492

MICRO SURGICAL INSTRUMENT SYSTEM by Tava Surgical Instruments — Product Code HSZ

K884492 is an FDA 510(k) premarket notification submitted by Tava Surgical Instruments for the device "MICRO SURGICAL INSTRUMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on November 16, 1988. The device falls under product code HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Tava Surgical Instruments has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1988
Date Received
October 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type

Other clearances by Tava Surgical Instruments

  • K935367 — TAVA WIRE-DRIVER (April 21, 1994)
  • K940109 — TAVA K-WIRE (February 22, 1994)
  • K885273 — MICRO SURGICAL INSTRUMENT SYSTEM (January 30, 1989)
  • K872475 — SURGICAL BUR (July 2, 1987)
  • K863788 — SAWBLADE (October 14, 1986)
  • K854543 — PULSE LAVAGE (January 27, 1986)

Other clearances for product code HSZ

  • K991588 — EMS SWISS ORTHOCLAST (July 21, 1999)
  • K972860 — CURVTEK TSR SYSTEM (October 31, 1997)
  • K970345 — ALIGNMENT INSTRUMENT (April 29, 1997)
  • K955084 — ASPACH 65,000 (MODIFICATION) (January 17, 1996)
  • K954080 — SODEM HIGH SPEED SYSTEM (October 16, 1995)
  • K944590 — ETHICON DRILL BIT AND DRILL GUIDE (May 11, 1995)
  • K934336 — SPINALPLANE (March 10, 1995)
  • K940276 — FILTER, DIFFUSER (November 16, 1994)
  • K942760 — PNEUMATIC WIRE TENSIONER (September 6, 1994)
  • K941681 — ARTHREX CIRCULAR HARVESTING SAW (August 25, 1994)

FDA data resources