EVOTECH ECR— 510(k) K152189

Clearance details

Applicant

Advanced Sterilization Products (Asp)

Product code

Code FEB

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2015-08-05

Decision date

2016-07-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Irvin, CA, US

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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

• K192025 — STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader2020-01-23
• K181472 — AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor2019-04-23
• K182404 — STERRAD VELOCITY Biological Indicator2018-12-27
• K170039 — STERRAD VELOCITY Biological Indictator and Reader2017-06-20

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 →

• Z-0965-2017 — EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60¿C} semi-critical endoscopes.Class II·Terminated·Advanced Sterilization Products·20160927

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152189.