HBC · Class II · 21 CFR 882.4360

FDA Product Code HBC: Motor, Drill, Electric

Leading manufacturers include Aesculap, Inc., The Anspach Effort, Inc. and Saeshin Precision Co., Ltd..

26
Total
26
Cleared
146d
Avg days
1981
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 361d recently vs 128d historically

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 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 Apr 29, 2009
PRIMADO
K083112
Nakanishi, Inc.
Neurology · 190d
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 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

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 increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - HBC Product Code

Recent submissions under HBC have taken an average of 361 days to reach a decision - up from 128 days historically. Manufacturers should account for longer review timelines in current project planning.

HBC devices are reviewed by the Neurology panel. Browse all Neurology devices →