FDA product code EQJ: Bur, Ear, Nose And Throat
EQJ is the FDA product code for bur, ear, nose and throat. It is a Class I device, regulated under 21 CFR 874.4140 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 18 510(k) submissions under EQJ, from 12 different applicants. The average 510(k) review took 78 days (median 48). FDA has posted 4 recalls for EQJ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bur, Ear, Nose And Throat |
| Device class | Class I |
| Regulation | 21 CFR 874.4140 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
510(k) clearances per year for EQJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 229 |
Compare with all 510(k) review times · Search every EQJ clearance
Top EQJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Trebay Medical Corp. | 5 | 1996-01-30 |
| KARL STORZ Endoscopy-America, Inc. | 3 | 1995-09-06 |
| Stryker Corporation | 1 | 2017-01-17 |
| Medtronic Xomed, Inc. | 1 | 2004-08-12 |
| Gyrus Ent LLC | 1 | 1998-01-12 |
7 more applicants have EQJ clearances. See the full list in Caduvo.
Most recent EQJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K161514 | Stryker Corporation | Precision Thin Reciprocating Blade, 0.010in. | 2017-01-17 | 229 |
| K041985 | Medtronic Xomed, Inc. | XPS CURVED BUR | 2004-08-12 | 20 |
| K974232 | Gyrus Ent LLC | ESSENTIAL SHAVER SYSTEM | 1998-01-12 | 61 |
| K960853 | Xomed, Inc. | ACE SYSTEM | 1996-04-03 | 33 |
| K955704 | Trebay Medical Corp. | TREBAY MICRODEBRIDER SYSTEM | 1996-01-30 | 46 |
Recalls for EQJ devices
4 product recalls in 4 recall events; 1 initiated in the last five years and 3 still open. Most recent: 2024-07-05.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2021 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code EQJ?
EQJ is the FDA product code for bur, ear, nose and throat. It is a Class I device, regulated under 21 CFR 874.4140 and reviewed by the Ear, Nose and Throat panel.
What device class is EQJ?
Class I, regulation 21 CFR 874.4140. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EQJ?
Across 18 cleared submissions the average was 78 days from receipt to decision (median 48).
Which companies have the most EQJ clearances?
Trebay Medical Corp. (5); KARL STORZ Endoscopy-America, Inc. (3); Stryker Corporation (1); Medtronic Xomed, Inc. (1); Gyrus Ent LLC (1).
Have EQJ devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2024-07-05.
Next steps
- Run an FDA pathway report with predicate devices for product code EQJ
- Run a recall and safety report across every EQJ manufacturer
- Watch product code EQJ 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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