HBC · Class II · 21 CFR 882.4360

FDA Product Code HBC: Motor, Drill, Electric

Leading manufacturers include Aesculap, Inc., The Anspach Effort, Inc. and Medtronic Powered Surgical Solutions.

26
Total
26
Cleared
146d
Avg days
1981
Since
Declining activity - 0 submissions in the last 2 years vs 3 in the prior period

FDA 510(k) Cleared Motor, Drill, Electric Devices (Product Code HBC)

26 devices
1–24 of 26
Cleared Sep 20, 2024
Traus SSG10 Surgical System
K233153
Saeshin Precision Co., Ltd.
Neurology · 359d
Cleared Sep 16, 2024
Traus SSG30 Surgical System
K232938
Saeshin Precision Co., Ltd.
Neurology · 362d
Cleared Oct 31, 2022
ORiGO System
K213697
Bien-Air Surgery SA
Neurology · 342d
Cleared May 19, 2022
Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
K220485
The Anspach Effort, Inc.
Neurology · 91d
Cleared Apr 09, 2021
hekaDrill
K193630
Zethon, Ltd.
Neurology · 470d
Cleared May 12, 2019
MR8 Drill System, Midas Rex MR8 ClearView Tools
K183515
Medtronic Powered Surgical Solutions
Neurology · 145d
Cleared Jun 22, 2018
OSSEODUO Shaver and Drill System
K173066
Bien-Air Surgery SA
Neurology · 266d
Cleared May 15, 2017
IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools
K170312
Medtronic Powered Surgical Solutions
Neurology · 103d
Cleared Mar 28, 2017
MR8 Drill System
K163565
Medtronic Powered Surgical Solutions
Neurology · 99d
Cleared Jul 22, 2016
ELAN 4 Motor System
K152960
Aesculap, Inc.
Neurology · 289d
Cleared Jan 10, 2014
ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS
K133604
The Anspach Effort, Inc.
Neurology · 46d
Cleared Dec 17, 2013
PRIMADO2 TOTAL SURGICAL SYSTEM
K132264
Nakanishi, Inc.
Neurology · 148d
Cleared Mar 29, 2013
D4000 DRIVE SYSTEM
K130497
Linvatec Corporation D/B/A Conmed Linvatec
Neurology · 31d
Cleared Apr 29, 2009
PRIMADO
K083112
Nakanishi, Inc.
Neurology · 190d
Cleared Apr 02, 2008
CONMED LINVATEC OSPREY DRILL SYSTEM
K080444
Conmed Linvatec
Neurology · 43d
Cleared Apr 10, 2006
MICROPOWER HAND PIECE HIGH SPEED DRILL
K060260
Linvatec Corp.
Neurology · 68d
Cleared Jan 18, 2006
MICROSPEED UNI MOTOR SYSTEM
K053526
Aesculap, Inc.
Neurology · 30d
Cleared Nov 19, 2002
THE BIOPLATE BATTERY POWERED DRILL
K022986
Bioplate, Inc.
Neurology · 71d
Cleared Aug 08, 2001
ANSPACH EMAX DRILL SYSTEM
K011444
The Anspach Effort, Inc.
Neurology · 89d
Cleared Feb 20, 2001
MICROSPEED EC MOTORSYSTEM GD650/GD653
K003612
Aesculap, Inc.
Neurology · 90d
Cleared Oct 06, 2000
ADVANTAGE DRIVE SYSTEM
K002523
Linvatec Corp.
Neurology · 52d
Cleared Jan 16, 1998
SERVOTRONIC EC100 SYSTEM
K972857
Medicon EG
Neurology · 168d

About Product Code HBC - Regulatory Context

510(k) Submission Activity

26 total 510(k) submissions under product code HBC since 1981, with 26 receiving FDA clearance (average review time: 146 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.