FDA product code QSW: Endoscopic Traction Device
QSW is the FDA product code for endoscopic traction device. It is a Class II device, regulated under 21 CFR 876.4410 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under QSW, 1 in the last five years. The average 510(k) review took 60 days (median 60). 1 De Novo request was granted under it.
Definition
An endoscopic traction device is a prescription device that is endoscopically applied to retract tissue in the gastrointestinal tract during dissection procedures to increase visualization of the dissection plane and assist in tissue resection, exposure, and removal.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Traction Device |
| Device class | Class II |
| Regulation | 21 CFR 876.4410 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for QSW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 60 |
Compare with all 510(k) review times · Search every QSW clearance
Top QSW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | 1 | 2022-10-03 |
Most recent QSW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222354 | Micro-Tech (Nanjing) Co., Ltd. | Elastic Traction System | 2022-10-03 | 60 |
Recalls for QSW devices
openFDA lists no recalls for product code QSW.
Frequently asked questions
What is FDA product code QSW?
QSW is the FDA product code for endoscopic traction device. It is a Class II device, regulated under 21 CFR 876.4410 and reviewed by the Gastroenterology and Urology panel.
What device class is QSW?
Class II, regulation 21 CFR 876.4410. Typical premarket route: 510(k).
How long does a 510(k) take for product code QSW?
Across 1 cleared submissions the average was 60 days from receipt to decision (median 60).
Which companies have the most QSW clearances?
Micro-Tech (Nanjing) Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QSW
- Run a recall and safety report across every QSW manufacturer
- Watch product code QSW 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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