ERL · Class II · 21 CFR 874.4250

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

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Stryker Corporation and The Anspach Effort, 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 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 Dec 19, 2005
KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES
K053262
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 27d
Cleared Apr 13, 2001
KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES
K003994
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 108d
Cleared Mar 24, 1995
KARL STORZ INTRA-HANDPIECES AND ACCESSORIES
K950964
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 22d

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 →