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510(k) K914845

M170 PNEUMATICALLY OPERATED OSCILLATING SAW by Desutter Medical , Ltd. — Product Code HSZ

K914845 is an FDA 510(k) premarket notification submitted by Desutter Medical , Ltd. for the device "M170 PNEUMATICALLY OPERATED OSCILLATING SAW". The FDA issued a decision of Substantially Equivalent on January 13, 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1992
Date Received
October 28, 1991
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

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  • 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