enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System— 510(k) K243433

Name: FDA 510(k) clearance K243433
Creator: U.S. Food and Drug Administration
Published: 2024-12-02

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K243433 for enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System, Substantially Equivalent on 2024-12-02. Applicant: STERIS Corporation. Device class: 2.

Clearance details

Applicant: STERIS Corporation
Product code: Code FEB
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2024-11-05
Decision date: 2024-12-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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K230930 — enspire 3000 Cleaning and Liquid Chemical Sterile Processing System2023-06-30
K213833 — SCOPE BUDDY PLUS Endoscope Flushing Aid2022-01-14
K201920 — Endoscope Reprocessor OER-Elite2020-09-01
K173590 — System 83 Plus Washer/Disinfector2020-03-30

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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.