Cleared Traditional

ENDO-SPONGE

K892218 · Endovations · Gastroenterology & Urology
May 1989
Decision
58d
Days
Class 1
Risk

About This 510(k) Submission

K892218 is an FDA 510(k) clearance for the ENDO-SPONGE, a Accessories, Cleaning Brushes, For Endoscope (Class I — General Controls, product code MNL), submitted by Endovations (Mechanicsburg, US). The FDA issued a Cleared decision on May 31, 1989, 58 days after receiving the submission on April 3, 1989. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K892218 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 1989
Decision Date May 31, 1989
Days to Decision 58 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