ERLClass II
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
21 CFR 874.4250 / Ear, Nose, Throat
ERL is the FDA product code for Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, a class II device type, regulated under 21 CFR 874.4250. As of , FDA records hold 91 510(k) clearances under this code, the most recent dated , and 29 recalls.
Classification record
- Product code
- ERL
- Device name
- Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- Regulation
- 21 CFR 874.4250
- Device class
- Class II
- Review panel
- Ear, Nose, Throat
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 91
- Ingested recalls
- 29
Clearances, product code ERL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1979 | 2 |
| 1980 | 1 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 3 |
| 1986 | 3 |
| 1987 | 1 |
| 1991 | 2 |
| 1994 | 5 |
| 1995 | 8 |
| 1996 | 3 |
| 1997 | 8 |
| 1998 | 5 |
| 1999 | 2 |
| 2000 | 2 |
| 2001 | 4 |
| 2002 | 3 |
| 2003 | 1 |
| 2004 | 4 |
| 2005 | 1 |
| 2008 | 6 |
| 2009 | 1 |
| 2012 | 2 |
| 2013 | 2 |
| 2014 | 1 |
| 2015 | 3 |
| 2016 | 4 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 3 |
| 2024 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code ERL| Applicant | Clearances |
|---|---|
| Stryker Corp. | 13 |
| Medtronic Xomed, Inc. | 8 |
| Karl Storz Endoscopy-America, Inc. | 5 |
| Linvatec Corporation | 5 |
| Gyrus Ent LLC | 4 |
| Bien-Air Surgery SA | 3 |
| Gyrus ACMI, Inc. | 3 |
| Laurimed, LLC | 3 |
| The Anspach Effort, Inc. | 3 |
| Xomed, Inc. | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.