HBC · Motor, Drill, Electric
Neurology · 21 CFR 882.4360 · Class 2
Overview
| Product Code | HBC |
|---|---|
| Device Name | Motor, Drill, Electric |
| Regulation | 21 CFR 882.4360 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 26)
Showing 20 most recent of 26 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233153 | Traus SSG10 Surgical System | Saeshin Precision Co., Ltd. | Sep 20, 2024 | SESE |
| K232938 | Traus SSG30 Surgical System | Saeshin Precision Co., Ltd. | Sep 16, 2024 | SESE |
| K213697 | ORiGO System | Bien-Air Surgery SA | Oct 31, 2022 | SESE |
| K220485 | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) | The Anspach Effort, Inc. | May 19, 2022 | SESE |
| K193630 | hekaDrill | Zethon, Ltd. | Apr 9, 2021 | SESE |
| K183515 | MR8 Drill System, Midas Rex MR8 ClearView Tools | Medtronic Powered Surgical Solutions | May 12, 2019 | SESE |
| K173066 | OSSEODUO Shaver and Drill System | Bien-Air Surgery SA | Jun 22, 2018 | SESE |
| K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools | Medtronic Powered Surgical Solutions | May 15, 2017 | SESE |
| K163565 | MR8 Drill System | Medtronic Powered Surgical Solutions | Mar 28, 2017 | SESE |
| K152960 | ELAN 4 Motor System | Aesculap, Inc. | Jul 22, 2016 | SESE |
| K133604 | ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS | The Anspach Effort, Inc. | Jan 10, 2014 | SESE |
| K132264 | PRIMADO2 TOTAL SURGICAL SYSTEM | Nakanishi, Inc. | Dec 17, 2013 | SESE |
| K130497 | D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION | Linvatec Corporation D/B/A Conmed Linvatec | Mar 29, 2013 | SESE |
| K083112 | PRIMADO | Nakanishi, Inc. | Apr 29, 2009 | SESE |
| K080444 | CONMED LINVATEC OSPREY DRILL SYSTEM | Conmed Linvatec | Apr 2, 2008 | SESE |
| K060260 | MICROPOWER HAND PIECE HIGH SPEED DRILL | Linvatec Corp. | Apr 10, 2006 | SESE |
| K053526 | MICROSPEED UNI MOTOR SYSTEM | Aesculap, Inc. | Jan 18, 2006 | SESE |
| K022986 | THE BIOPLATE BATTERY POWERED DRILL | Bioplate, Inc. | Nov 19, 2002 | SESE |
| K012457 | SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) | Sodemsystems | Oct 22, 2001 | SESE |
| K012453 | SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY) | Sodemsystems | Oct 22, 2001 | SESE |
Top Applicants
- Aesculap, Inc. — 3 clearances
- Medtronic Powered Surgical Solutions — 3 clearances
- The Anspach Effort, Inc. — 3 clearances
- Bien-Air Surgery SA — 2 clearances
- Linvatec Corp. — 2 clearances
