HBC — Motor, Drill, Electric Class II
FDA product code HBC covers "Motor, Drill, Electric", a Class II medical device regulated under 21 CFR 882.4360. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HBC
- Device Class
- Class II
- Regulation Number
- 882.4360
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233153 | saeshin precision co | Traus SSG10 Surgical System | September 20, 2024 |
| K232938 | saeshin precision co | Traus SSG30 Surgical System | September 16, 2024 |
| K213697 | bien-air surgery | ORiGO System | October 31, 2022 |
| K220485 | anspach effort | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, E | May 19, 2022 |
| K193630 | zethon | hekaDrill | April 9, 2021 |
| K183515 | medtronic powered surgical solutions | MR8 Drill System, Midas Rex MR8 ClearView Tools | May 12, 2019 |
| K173066 | bien-air surgery | OSSEODUO Shaver and Drill System | June 22, 2018 |
| K170312 | medtronic powered surgical solutions | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw h | May 15, 2017 |
| K163565 | medtronic powered surgical solutions | MR8 Drill System | March 28, 2017 |
| K152960 | aesculap | ELAN 4 Motor System | July 22, 2016 |
| K133604 | anspach effort | ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS | January 10, 2014 |
| K132264 | nakanishi | PRIMADO2 TOTAL SURGICAL SYSTEM | December 17, 2013 |
| K130497 | linvatec corporation d/b/a conmed linvatec | D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION | March 29, 2013 |
| K083112 | nakanishi | PRIMADO | April 29, 2009 |
| K080444 | conmed linvatec | CONMED LINVATEC OSPREY DRILL SYSTEM | April 2, 2008 |
| K060260 | linvatec | MICROPOWER HAND PIECE HIGH SPEED DRILL | April 10, 2006 |
| K053526 | aesculap | MICROSPEED UNI MOTOR SYSTEM | January 18, 2006 |
| K022986 | bioplate | THE BIOPLATE BATTERY POWERED DRILL | November 19, 2002 |
| K012457 | sodemsystems | SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) | October 22, 2001 |
| K012453 | sodemsystems | SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY) | October 22, 2001 |