Cleared Traditional

K874239 - CLEANING BRUSH
(FDA 510(k) Clearance)

Dec 1987
Decision
74d
Days
Class 1
Risk

K874239 is an FDA 510(k) clearance for the CLEANING BRUSH. This device is classified as a Accessories, Cleaning Brushes, For Endoscope (Class I - General Controls, product code MNL).

Submitted by Endovations (Camp Hill, US). The FDA issued a Cleared decision on December 29, 1987, 74 days after receiving the submission on October 16, 1987.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K874239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1987
Decision Date December 29, 1987
Days to Decision 74 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary

Device Classification

Product Code MNL — Accessories, Cleaning Brushes, For Endoscope
Device Class Class I - General Controls
CFR Regulation 21 CFR 876.1500