FEB

Accessories, Cleaning, For Endoscope

Product code
FEB
Device name
Accessories, Cleaning, For Endoscope
Device class
Class 2
21 CFR
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
57 (all years; only the last 3 years are listed here)

FDA classification definition

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2024-12-19.

NumberDecision dateApplicantDevice nameSummary
K2411682024-12-19Wassenburg Medical, Inc.System 83 Revolve Endoscope Washer/DisinfectorPDF
K2434332024-12-02STERIS Corporationenspire 3000 Cleaning and Liquid Chemical Sterilant …PDF

2 summaries are archived here for direct download.

Official FDA classification page: FEB
Classification and pathway per current FDA publications. Data from openFDA (CC0).