FDA product code LJW: Tracheotome
LJW is the FDA product code for tracheotome. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 2 510(k) submissions under LJW, from 2 different applicants. The average 510(k) review took 188 days (median 188). FDA has posted 1 recall for LJW devices.
Classification
| Field | Value |
|---|---|
| Device name | Tracheotome |
| Device class | Class I |
| Regulation | 21 CFR 874.4420 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LJW clearance
Top LJW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wrightmedicaltechnologyinc | 1 | 1994-03-07 |
| Kelleher Corp. | 1 | 1983-01-28 |
Most recent LJW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K933570 | Wrightmedicaltechnologyinc | RESOLUTION(TM) HIP STEM | 1994-03-07 | 227 |
| K822618 | Kelleher Corp. | EMERGENCY TRACHEOSTOMY INSTRUMENT SET | 1983-01-28 | 148 |
Recalls for LJW devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-09-07.
Frequently asked questions
What is FDA product code LJW?
LJW is the FDA product code for tracheotome. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.
What device class is LJW?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LJW?
Across 2 cleared submissions the average was 188 days from receipt to decision (median 188).
Which companies have the most LJW clearances?
Wrightmedicaltechnologyinc (1); Kelleher Corp. (1).
Have LJW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-09-07.
Next steps
- Run an FDA pathway report with predicate devices for product code LJW
- Run a recall and safety report across every LJW manufacturer
- Watch product code LJW 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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