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510(k) K922661

HHI PNEUMATIC ROTARY DRILL by H&H Instruments — Product Code HSZ

K922661 is an FDA 510(k) premarket notification submitted by H&H Instruments for the device "HHI PNEUMATIC ROTARY DRILL". The FDA issued a decision of Substantially Equivalent on September 18, 1992. The device falls under product code HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. H&H Instruments has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1992
Date Received
June 3, 1992
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 H&H Instruments

  • K922056 — HHI ELECTRIC CONSOLE #875-000 (September 18, 1992)

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