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510(k) K822790

MICRO-CRAFT OSCILLATING SAW HANDPIECE by Xomed, Inc. — Product Code KIJ

K822790 is an FDA 510(k) premarket notification submitted by Xomed, Inc. for the device "MICRO-CRAFT OSCILLATING SAW HANDPIECE". The FDA issued a decision of Substantially Equivalent on October 22, 1982. The device falls under product code KIJ (Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Xomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1982
Date Received
September 15, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type

Other clearances by Xomed, Inc.

  • K002395 — MODEL 30 CLASSIC PNEUMATONOMETER (December 11, 2000)
  • K002987 — REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE (December 4, 2000)
  • K002828 — XPS NITRO SYSTEM (October 17, 2000)
  • K002897 — TITANIUM MIDDLE EAR PROSTHESES (October 11, 2000)
  • K993653 — MICRO-FRANCE TROCARS AND ACCESSORIES (June 9, 2000)
  • K001148 — MEROGEL OTOLOGIC PACK (June 3, 2000)
  • K994262 — FRONTAL SINUS TREPHINATION CANNULA (February 8, 2000)
  • K992855 — XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT (January 21, 2000)
  • K993582 — MODIFICATION TO LASER-SHIELD II (January 20, 2000)
  • K993655 — MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS (December 21, 1999)

Other clearances for product code KIJ

  • K163308 — SMARTO (December 27, 2016)
  • K112599 — INSURGICAL SINGLE USE POWER EQUIPMENT (November 6, 2012)
  • K101563 — SMARTO (December 17, 2010)
  • K972367 — STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT (September 4, 1997)
  • K970378 — STRYKER 2115 REPLACEMENT BATTERY (2115) (April 30, 1997)
  • K960711 — ACUMED BONE GRAFT SYSTEM (May 7, 1996)
  • K951450 — SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY (May 17, 1995)
  • K944488 — S & S ORTHOPEDIC WIRE DRIVER 701 (March 2, 1995)
  • K941285 — ARTHREX GRAFT HARVESTING KIT (November 14, 1994)
  • K933101 — THE OSTEOMED B POWER SYSTEM AND ACCESSORIES (November 7, 1994)

FDA data resources