FDA product code LWI: Ultrasound, Sinus
LWI is the FDA product code for ultrasound, sinus. It is a Class II device, regulated under 21 CFR 892.1560 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 4 510(k) submissions under LWI, from 4 different applicants. The average 510(k) review took 202 days (median 149).
Classification
| Field | Value |
|---|---|
| Device name | Ultrasound, Sinus |
| Device class | Class II |
| Regulation | 21 CFR 892.1560 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every LWI clearance
Top LWI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ferguson Medical | 1 | 1997-04-16 |
| Entlab OY | 1 | 1996-08-02 |
| Custom Pack Reliability | 1 | 1996-03-22 |
| Pie Data Medical BV | 1 | 1987-12-31 |
Most recent LWI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K960421 | Ferguson Medical | SINUSCAN 102/SINUSPRINT | 1997-04-16 | 443 |
| K960044 | Entlab OY | ULTRAMAX/MODEL NUMBER A1 | 1996-08-02 | 213 |
| K960241 | Custom Pack Reliability | CPR GENERAL SURGERY TRAY | 1996-03-22 | 66 |
| K874081 | Pie Data Medical BV | ENTERSCAN | 1987-12-31 | 85 |
Recalls for LWI devices
openFDA lists no recalls for product code LWI.
Frequently asked questions
What is FDA product code LWI?
LWI is the FDA product code for ultrasound, sinus. It is a Class II device, regulated under 21 CFR 892.1560 and reviewed by the Ear, Nose and Throat panel.
What device class is LWI?
Class II, regulation 21 CFR 892.1560. Typical premarket route: 510(k).
How long does a 510(k) take for product code LWI?
Across 4 cleared submissions the average was 202 days from receipt to decision (median 149).
Which companies have the most LWI clearances?
Ferguson Medical (1); Entlab OY (1); Custom Pack Reliability (1); Pie Data Medical BV (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LWI
- Run a recall and safety report across every LWI manufacturer
- Watch product code LWI 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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