hekaDrill
FDA 510(k) K193630 · Zethon, Ltd.
510(k) numberK193630
Submission
- Device name
- hekaDrill
- Applicant
- Zethon, Ltd.
Aston Clinton, GB - Received
- December 26, 2019
- Decision date
- April 9, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K254174 | Surgical Power SystemHBC · Traditional | Guizhou Zirui Technology Co., Ltd. | 09/11/2026SE |
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| K183515 | MR8 Drill System, Midas Rex MR8 ClearView ToolsHBC · Traditional | Medtronic Powered Surgical Solutions | 05/12/2019SE |
| K173066 | OSSEODUO Shaver and Drill SystemHBC · Traditional | Bien-Air Surgery SA | 06/22/2018SE |
| K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw…HBC · Traditional | Medtronic Powered Surgical Solutions | 05/15/2017SE |
| K163565 | MR8 Drill SystemHBC · Traditional | Medtronic Powered Surgical Solutions | 03/28/2017SE |
| K152960 | ELAN 4 Motor SystemHBC · Traditional | Aesculap, Inc. | 07/22/2016SE |
More from Aesculap, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233958 | hekaDrillERL · Traditional | 03/14/2024SE |
Questions and answers
When was hekaDrill cleared by the FDA?
hekaDrill (K193630) received a 510(k) decision of Substantially Equivalent on April 9, 2021, 470 days after the submission was received.
What is the product code of K193630?
The FDA product code is HBC – Motor, Drill, Electric, a Class II (moderate risk) device regulated under 21 CFR 882.4360.