FDA product code SEW: Automated Endoscope Channel Cleaner
SEW is the FDA product code for automated endoscope channel cleaner. It is a Class II device, regulated under 21 CFR 880.6994 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under SEW, 1 in the last five years. The average 510(k) review took 157 days (median 157); 157 days on average over the last three years. 1 De Novo request was granted under it.
Definition
An automated endoscope channel cleaner is a device intended to replace all or a portion of manual cleaning of internal passages and ports of compatible reusable flexible endoscopes. Cleaning is conducted using an agent that exerts physical force (e.g., friction) on single or multiple channels of compatible endoscopes for removal of soil. This device type is not intended to provide or replace high-level disinfection or sterilization.
Classification
| Field | Value |
|---|---|
| Device name | Automated Endoscope Channel Cleaner |
| Device class | Class II |
| Regulation | 21 CFR 880.6994 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for SEW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 157 |
Compare with all 510(k) review times · Search every SEW clearance
Top SEW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nanosonics Limited | 1 | 2026-03-05 |
Most recent SEW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253267 | Nanosonics Limited | CORIS System | 2026-03-05 | 157 |
Recalls for SEW devices
openFDA lists no recalls for product code SEW.
Frequently asked questions
What is FDA product code SEW?
SEW is the FDA product code for automated endoscope channel cleaner. It is a Class II device, regulated under 21 CFR 880.6994 and reviewed by the General Hospital panel.
What device class is SEW?
Class II, regulation 21 CFR 880.6994. Typical premarket route: 510(k).
How long does a 510(k) take for product code SEW?
Across 1 cleared submissions the average was 157 days from receipt to decision (median 157).
Which companies have the most SEW clearances?
Nanosonics Limited (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SEW
- Run a recall and safety report across every SEW manufacturer
- Watch product code SEW 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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