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510(k) K930784

THE DE SOUTTER M193 REAMER by De Soutter Medical, Ltd. — Product Code HSZ

K930784 is an FDA 510(k) premarket notification submitted by De Soutter Medical, Ltd. for the device "THE DE SOUTTER M193 REAMER". The FDA issued a decision of Substantially Equivalent on October 27, 1993. The device falls under product code HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. De Soutter Medical, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1993
Date Received
February 16, 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 De Soutter Medical, Ltd.

  • K930785 — THE DE SOUTTER M182 DRILL (October 27, 1993)

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