SCOPE BUDDY PLUS Endoscope Flushing Aid— 510(k) K213833

Name: FDA 510(k) clearance K213833
Creator: U.S. Food and Drug Administration
Published: 2022-01-14

Substantially Equivalent

Medivators, Inc.

FDA 510(k) clearance K213833 for SCOPE BUDDY PLUS Endoscope Flushing Aid, Substantially Equivalent on 2022-01-14. Applicant: Medivators, Inc.. Device class: 2.

Clearance details

Applicant: Medivators, Inc.
Product code: Code FEB
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2021-12-09
Decision date: 2022-01-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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K201920 — Endoscope Reprocessor OER-Elite2020-09-01
K173590 — System 83 Plus Washer/Disinfector2020-03-30

More clearances from Medivators, Inc.

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K223040 — Endo SmartCap2023-03-01
K172677 — Advantage Plus Pass-Thru2017-12-19
K162128 — Scope Buddy Plus Endoscope Flushing Aid2016-12-21
K160846 — AmplifEYE2016-07-14
K152394 — Rapicide PA High-Level Disinfectant Test Strips2016-03-11

Adverse events under product code FEB

product code FEB

Malfunction: 3,879
Total: 3,879

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.