FDA product code JEK: Forceps, Biopsy, Bronchoscope (Rigid)
JEK is the FDA product code for forceps, biopsy, bronchoscope (rigid). It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 3 510(k) submissions under JEK, from 2 different applicants. The average 510(k) review took 49 days (median 33).
Definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Forceps, Biopsy, Bronchoscope (Rigid) |
| Device class | Class II |
| Regulation | 21 CFR 874.4680 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every JEK clearance
Top JEK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kelleher Corp. | 2 | 1982-08-25 |
| Pilling Weck Surgical | 1 | 1999-05-14 |
Most recent JEK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K990561 | Pilling Weck Surgical | OPTICAL FORCEPS | 1999-05-14 | 81 |
| K822198 | Kelleher Corp. | MALLEUS NIPPERS | 1982-08-25 | 33 |
| K822193 | Kelleher Corp. | FORCEPS FOR USE WITH RIGID ENDOSCOPES | 1982-08-24 | 32 |
Recalls for JEK devices
openFDA lists no recalls for product code JEK.
Frequently asked questions
What is FDA product code JEK?
JEK is the FDA product code for forceps, biopsy, bronchoscope (rigid). It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel.
What device class is JEK?
Class II, regulation 21 CFR 874.4680. Typical premarket route: 510(k).
How long does a 510(k) take for product code JEK?
Across 3 cleared submissions the average was 49 days from receipt to decision (median 33).
Which companies have the most JEK clearances?
Kelleher Corp. (2); Pilling Weck Surgical (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JEK
- Run a recall and safety report across every JEK manufacturer
- Watch product code JEK 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.
All Ear, Nose and Throat product codes · FDA product code lookup · 510(k) database search · 510(k) review times