FDA product code QJN: Laparoscopic Accessories, Esophageal Sizing
QJN is the FDA product code for laparoscopic accessories, esophageal sizing. It is a Class II device, regulated under 21 CFR 876.5360 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under QJN, 1 in the last five years. The average 510(k) review took 54 days (median 54).
Definition
To laparoscopically measure an extraluminal dimensional parameter of a gastrointestinal organ.
Classification
| Field | Value |
|---|---|
| Device name | Laparoscopic Accessories, Esophageal Sizing |
| Device class | Class II |
| Regulation | 21 CFR 876.5360 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for QJN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 80 |
| 2023 | 1 | 28 |
Compare with all 510(k) review times · Search every QJN clearance
Top QJN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Torax Medical, Inc. | 2 | 2023-02-09 |
Most recent QJN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230089 | Torax Medical, Inc. | ETHICON LINX® Esophagus Sizing Tool | 2023-02-09 | 28 |
| K201035 | Torax Medical, Inc. | ETHICON Linx Esophagus Sizing Tool | 2020-07-09 | 80 |
Recalls for QJN devices
openFDA lists no recalls for product code QJN.
Frequently asked questions
What is FDA product code QJN?
QJN is the FDA product code for laparoscopic accessories, esophageal sizing. It is a Class II device, regulated under 21 CFR 876.5360 and reviewed by the Gastroenterology and Urology panel.
What device class is QJN?
Class II, regulation 21 CFR 876.5360. Typical premarket route: 510(k).
How long does a 510(k) take for product code QJN?
Across 2 cleared submissions the average was 54 days from receipt to decision (median 54).
Which companies have the most QJN clearances?
Torax Medical, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QJN
- Run a recall and safety report across every QJN manufacturer
- Watch product code QJN 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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