FDA product code ERL: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
ERL is the FDA product code for drill, surgical, ent (electric or pneumatic) including handpiece. It is a Class II device, regulated under 21 CFR 874.4250 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 91 510(k) submissions under ERL, 5 in the last five years, from 47 different applicants. The average 510(k) review took 100 days (median 77); 174 days on average over the last three years. FDA has posted 29 recalls for ERL devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece |
| Device class | Class II |
| Regulation | 21 CFR 874.4250 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for ERL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 99 |
| 2018 | 1 | 77 |
| 2019 | 1 | 269 |
| 2020 | 1 | 258 |
| 2021 | 1 | 27 |
| 2022 | 3 | 193 |
| 2024 | 1 | 90 |
| 2025 | 1 | 259 |
Compare with all 510(k) review times · Search every ERL clearance
Top ERL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Xomed, Inc. | 6 | 2015-08-14 |
| Stryker Corporation | 5 | 2021-06-09 |
| Xomed, Inc. | 5 | 2000-10-17 |
| Linvatec Corp. | 5 | 1998-07-20 |
| KARL STORZ Endoscopy-America, Inc. | 4 | 2020-10-22 |
42 more applicants have ERL clearances. See the full list in Caduvo.
Most recent ERL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243280 | W&H Dentalwerk Buermoos GmbH | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) | 2025-07-03 | 259 |
| K233958 | Zethon, Ltd. | hekaDrill | 2024-03-14 | 90 |
| K221184 | Bien-Air Surgery SA | ORiGO System | 2022-11-02 | 191 |
| K213221 | W&H Dentalwerk Buermoss GmbH | AMADEO, M-UK1015 (incl. attachments and accessories) | 2022-05-26 | 239 |
| K212650 | Gyrus Acmi, Inc. | Celeris, Disposable Sinus Debrider | 2022-01-19 | 149 |
Recalls for ERL devices
29 product recalls in 13 recall events; 1 initiated in the last five years and 5 still open. Most recent: 2021-12-15.
| Year | Recalls |
|---|---|
| 2020 | 6 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code ERL?
ERL is the FDA product code for drill, surgical, ent (electric or pneumatic) including handpiece. It is a Class II device, regulated under 21 CFR 874.4250 and reviewed by the Ear, Nose and Throat panel.
What device class is ERL?
Class II, regulation 21 CFR 874.4250. Typical premarket route: 510(k).
How long does a 510(k) take for product code ERL?
Across 91 cleared submissions the average was 100 days from receipt to decision (median 77).
Which companies have the most ERL clearances?
Medtronic Xomed, Inc. (6); Stryker Corporation (5); Xomed, Inc. (5); Linvatec Corp. (5); KARL STORZ Endoscopy-America, Inc. (4).
Have ERL devices been recalled?
Yes: 29 product recalls across 13 recall events; the most recent began 2021-12-15.
Next steps
- Run an FDA pathway report with predicate devices for product code ERL
- Run a recall and safety report across every ERL manufacturer
- Watch product code ERL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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