Home / 510(k) Clearances / K931395

510(k) K931395

SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM by Micro Surgical Instruments Corp. — Product Code KIJ

K931395 is an FDA 510(k) premarket notification submitted by Micro Surgical Instruments Corp. for the device "SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on January 28, 1994. 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. Micro Surgical Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1994
Date Received
March 19, 1993
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 Micro Surgical Instruments Corp.

  • K932492 — IMPLANTOLOGY MODULE, MODEL 2175 (October 5, 1993)
  • K930205 — ELECTRIC WIRE DRIVER, MODEL 2640E (August 2, 1993)
  • K914998 — MICROAIRE(R) FACIAL BONE PLATING SYSTEM (June 2, 1992)
  • K915139 — MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE (February 5, 1992)
  • K914346 — DRILL MODULES MODELS 2116/2117 (November 27, 1991)
  • K913369 — MICRO-AIRE MODEL 2060 (November 1, 1991)
  • K913266 — MICRO-AIRE MODEL 2050E/ELEC HANDPIECE/TROTTLELESS (October 21, 1991)
  • K910175 — FIXATION DEVICES AND BONE PLATE (June 21, 1991)
  • K905383 — 2710-000 OSCILLATING SAW, GENERAL ASSEMBLY (June 18, 1991)
  • K905207 — MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS (January 22, 1991)

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