510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SEWClass II

Automated Endoscope Channel Cleaner

21 CFR 880.6994 / General Hospital
FDA source (opens on fda.gov)

SEW is the FDA product code for Automated Endoscope Channel Cleaner, a class II device type, regulated under 21 CFR 880.6994. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SEW
Device name
Automated Endoscope Channel Cleaner
FDA 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.
Regulation
21 CFR 880.6994
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code SEW

By decision year
2 clearances under product code SEW with a decision year between 2025 and 2026, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SEW by decision year
YearClearances
20251
20261

Applicants with the most clearances

Product code SEW
Applicants holding the most 510(k) clearances under product code SEW
ApplicantClearances
Nanosonics Limited2

Companies listing this code with FDA

Companies whose registered establishments list this code