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510(k) K935367

TAVA WIRE-DRIVER by Tava Surgical Instruments — Product Code HSZ

K935367 is an FDA 510(k) premarket notification submitted by Tava Surgical Instruments for the device "TAVA WIRE-DRIVER". The FDA issued a decision of Substantially Equivalent on April 21, 1994. 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
April 21, 1994
Date Received
November 4, 1993
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

  • K940109 — TAVA K-WIRE (February 22, 1994)
  • K885273 — MICRO SURGICAL INSTRUMENT SYSTEM (January 30, 1989)
  • K884492 — MICRO SURGICAL INSTRUMENT SYSTEM (November 16, 1988)
  • 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