FDA product code NWS: Kit, Choledochoscope, Flexible And Rigid
NWS is the FDA product code for kit, choledochoscope, flexible and rigid. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under NWS. The average 510(k) review took 38 days (median 38).
Definition
Flexible and Rigid Choledochoscope Kit
Classification
| Field | Value |
|---|---|
| Device name | Kit, Choledochoscope, Flexible And Rigid |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NWS clearance
Top NWS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus Corp. | 1 | 1981-04-03 |
Most recent NWS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K810503 | Olympus Corp. | FLEXIBLE CHOLEDOCHOSCOPE/NEPHROSCOPE | 1981-04-03 | 38 |
Recalls for NWS devices
openFDA lists no recalls for product code NWS.
Frequently asked questions
What is FDA product code NWS?
NWS is the FDA product code for kit, choledochoscope, flexible and rigid. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is NWS?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code NWS?
Across 1 cleared submissions the average was 38 days from receipt to decision (median 38).
Which companies have the most NWS clearances?
Olympus Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NWS
- Run a recall and safety report across every NWS manufacturer
- Watch product code NWS 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 Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times