Home / 510(k) Clearances / K900033

510(k) K900033

MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS by Micro-Aire Surgical Instruments, Inc. — Product Code GEY

K900033 is an FDA 510(k) premarket notification submitted by Micro-Aire Surgical Instruments, Inc. for the device "MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on February 13, 1990. The device falls under product code GEY (Motor, Surgical Instrument, Ac-Powered), a Class I device regulated under 21 CFR 878.4820. Micro-Aire Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1990
Date Received
January 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Ac-Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Micro-Aire Surgical Instruments, Inc.

  • K904949 — A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS (November 26, 1990)
  • K903650 — OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305 (September 14, 1990)
  • K902676 — MICROGUARD, ORTHOPEDIC PIN PROTECTORS (September 14, 1990)
  • K903713 — OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229 (September 14, 1990)
  • K903664 — MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL (September 13, 1990)
  • K901967 — DENDIA WERK BURS AND CUTTING DISCS (July 13, 1990)
  • K902168 — ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS) (June 20, 1990)
  • K901735 — ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444 (June 20, 1990)
  • K900210 — BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500 (February 2, 1990)
  • K896280 — MICRO-AIRE OSCILLATING SAW BLADE 202C-25, 202C-50 (November 22, 1989)

Other clearances for product code GEY

  • K050519 — ADVANCED TURBO DRIVE SYSTEM (May 17, 2005)
  • K020621 — ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS (March 28, 2002)
  • K012738 — SYMPHONY GRAFT DELIVERY SYSTEM (GDS) (November 14, 2001)
  • K972308 — MEDNEXT 1000 DRILL (August 20, 1997)
  • K971941 — AQUA SPRAY (August 14, 1997)
  • K971782 — BONE AND MARROW COLLECTION SYSTEM KIT (July 29, 1997)
  • K971268 — BONE & MARROW CLLECTION SYSTEM (July 3, 1997)
  • K964252 — ORTHOCHUCK (May 27, 1997)
  • K970530 — ANSPACH LUBRICATING SYSTEM II (May 5, 1997)
  • K964073 — BME BONE DRILL BITS (November 14, 1996)

FDA data resources