Smarto
FDA 510(k) K101563 · Jeil Medical Corporation
510(k) numberK101563
Submission
- Device name
- Smarto
- Applicant
- Jeil Medical Corporation
Seoul, KR - Received
- June 4, 2010
- Decision date
- December 17, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KIJ – Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KIJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K163308 | SmartoKIJ · Special | Jeil Medical Corporation | 12/27/2016SE |
| K112599 | Insurgical Single Use Power EquipmentKIJ · Traditional | Insurgical, LLC | 11/06/2012SE |
| K972367 | Stryker System 4000 Heavy Duty Battery Powered EquipmentKIJ · Traditional | Stryker Instruments | 09/04/1997SE |
| K970378 | Stryker 2115 Replacement Battery (2115)KIJ · Traditional | Implant Resource, Inc. | 04/30/1997SE |
| K960711 | Acumed Bone Graft SystemKIJ · Traditional | Acu Med, Inc. | 05/07/1996SE |
| K951450 | System 2000 Replacement Battery, System 2000-EXTENDED Run Replacement BatteryKIJ · Traditional | Strenumed, Inc. | 05/17/1995SE |
| K944488 | S & S Orthopedic Wire Driver 701KIJ · Traditional | S & S Orthopedic , Ltd. | 03/02/1995SE |
| K941285 | Arthrex Graft Harvesting KitKIJ · Traditional | Arthrex, Inc. | 11/14/1994SE |
| K933101 | The Osteomed B Power System and AccessoriesKIJ · Traditional | Osteomed Corp. | 11/07/1994SE |
| K933337 | R and D Battery ReplacementKIJ · Traditional | R & D Batteries, Inc. | 04/05/1994SE |
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Questions and answers
When was Smarto cleared by the FDA?
Smarto (K101563) received a 510(k) decision of Substantially Equivalent on December 17, 2010, 196 days after the submission was received.
What is the product code of K101563?
The FDA product code is KIJ – Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.