Product code KIJ— General, Plastic Surgery
SMARTO
- Classification name
- Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- Device class
- Class 1
- Regulation
- 21 CFR 878.4820
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 29
- First cleared
- Most recent
Market context for product code KIJ
FDA has cleared devices under product code KIJ between 1978 and 2016, filed by 21 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2016
- 2012
- 2010
- 1997
- 1996
- 1995
- 1994
- 1988
- 1986
- 1985
- 1982
- 1980
- 1979
- 1978
Top applicants under product code KIJ
Recent clearances under product code KIJ
- K163308 — SMARTO
- K112599 — INSURGICAL SINGLE USE POWER EQUIPMENT
- K101563 — SMARTO
- K972367 — STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT
- K970378 — STRYKER 2115 REPLACEMENT BATTERY (2115)
- K960711 — ACUMED BONE GRAFT SYSTEM
- K951450 — SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY
- K944488 — S & S ORTHOPEDIC WIRE DRIVER 701
- K941285 — ARTHREX GRAFT HARVESTING KIT
- K933101 — THE OSTEOMED B POWER SYSTEM AND ACCESSORIES
- K933337 — R AND D BATTERY REPLACEMENT
- K931395 — SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM
- K932307 — 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM
- K884839 — MODIFIED SAW BLADES TO THE SAGITAL SAW
- K873766 — STERNAL POWER AWL
- K864137 — LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III
- K850789 — FLUTED SUCTION MENISCAL CUTTER
- K844162 — EZ 505
- K844163 — EZ 502
- K822790 — MICRO-CRAFT OSCILLATING SAW HANDPIECE
- K820367 — INTRA-ARTICULAR SURGICAL SYSTEM
- K800314 — POWER PACK
- K800315 — DUAL MPC CHARGER
- K800311 — 450 DRILL/800 DRILL
- K800312 — 150 DRIVER/REAMER
- K800313 — SAGITTAL SAW
- K790063 — DRILL, CORDLESS SURGICAL
- K780645 — HMD-2000 BATTERY-POWERED MINI-DRILL, THE
- K771218 — INTRA-ARTICULAR SHAVER
Data sourced from openFDA. This site is unofficial and independent of the FDA.