ERL · Class II · 21 CFR 874.4250

FDA Product Code ERL: Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

Leading manufacturers include Medtronic Xomed, Inc., Xomed, Inc. and KARL STORZ Endoscopy-America, Inc..

91
Total
91
Cleared
100d
Avg days
1978
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 259d recently vs 98d historically

FDA 510(k) Cleared Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece Devices (Product Code ERL)

91 devices
1–24 of 91
Cleared Jul 03, 2025
Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)
K243280
W&H Dentalwerk Buermoos GmbH
Ear, Nose, Throat · 259d
Cleared Mar 14, 2024
hekaDrill
K233958
Zethon, Ltd.
Ear, Nose, Throat · 90d
Cleared Nov 02, 2022
ORiGO System
K221184
Bien-Air Surgery SA
Ear, Nose, Throat · 191d
Cleared May 26, 2022
AMADEO, M-UK1015 (incl. attachments and accessories)
K213221
W&H Dentalwerk Buermoss GmbH
Dental · 239d
Cleared Jan 19, 2022
Celeris, Disposable Sinus Debrider
K212650
Gyrus Acmi, Inc.
Ear, Nose, Throat · 149d
Cleared Jun 09, 2021
Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
K211490
Stryker Corporation
Ear, Nose, Throat · 27d
Cleared Oct 22, 2020
UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece
K200318
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 258d
Cleared Dec 13, 2019
EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand
K190715
Interscope, Inc.
Ear, Nose, Throat · 269d
Cleared Mar 27, 2018
OCM-G1 Attachment
K180063
The Anspach Effort, Inc.
Ear, Nose, Throat · 77d
Cleared Sep 15, 2017
Stryker Consolidated Operating Room Equipment (CORE) 2 Console
K171840
Stryker Corporation
Ear, Nose, Throat · 87d
Cleared Jun 10, 2016
DIEGO ELITE DRILL
K152744
Gyrus Acmi, Inc.
Ear, Nose, Throat · 261d
Cleared Jan 08, 2016
Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces
K150969
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 270d
Cleared Nov 20, 2015
Pi Drive Plus Motor, Extender
K152641
Stryker Corporation
Ear, Nose, Throat · 66d
Cleared Aug 14, 2015
XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole
K150728
Medtronic Xomed, Inc.
Ear, Nose, Throat · 147d
Cleared Sep 26, 2014
STRYKER S2 DRILL
K141935
Stryker Corporation
Ear, Nose, Throat · 71d
Cleared Dec 31, 2013
ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM
K131053
The Anspach Effort, Inc.
Ear, Nose, Throat · 259d
Cleared Aug 30, 2012
DTAD
K121678
Gyrus Acmi, Inc.
Ear, Nose, Throat · 84d
Cleared May 01, 2012
STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
K112593
Stryker Corporation
Ear, Nose, Throat · 237d
Cleared Dec 17, 2008
REPROCESSED ENT SHAVERS
K081814
Sterilmed, Inc.
Ear, Nose, Throat · 174d
Cleared Oct 02, 2008
STRYKER ESSX WITH NAVIGATION MOUNT
K080052
Stryker Corp.
Ear, Nose, Throat · 268d
Cleared Sep 17, 2008
PRIMADO SURGICAL DRILL
K080722
Nakanishi, Inc.
Ear, Nose, Throat · 188d
Cleared Sep 05, 2008
XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)
K081277
Medtronic Xomed, Inc.
Ear, Nose, Throat · 123d
Cleared Mar 24, 2008
XPS 3000 SYSTEM
K073255
Medtronic Xomed, Inc.
Ear, Nose, Throat · 126d
Cleared Dec 19, 2005
KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES
K053262
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 27d

About Product Code ERL - Regulatory Context

510(k) Submission Activity

91 total 510(k) submissions under product code ERL since 1978, with 91 receiving FDA clearance (average review time: 100 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - ERL Product Code

Recent submissions under ERL have taken an average of 259 days to reach a decision - up from 98 days historically. Manufacturers should account for longer review timelines in current project planning.

ERL devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →