Acu-sInQ Complete Endoscope Cleaning Aid System— 510(k) K181865
Substantially EquivalentSTERIS Corporation
FDA 510(k) clearance K181865 for Acu-sInQ Complete Endoscope Cleaning Aid System, Substantially Equivalent on 2018-12-14. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mentor, OH, US
Recent devices under product code FEB
view all- K241168 — System 83 Revolve Endoscope Washer/Disinfector
- K243433 — enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
- K230930 — enspire 3000 Cleaning and Liquid Chemical Sterile Processing System
- K213833 — SCOPE BUDDY PLUS Endoscope Flushing Aid
- K201920 — Endoscope Reprocessor OER-Elite
More clearances from STERIS Corporation
view allAdverse events under product code FEB
product code FEB- Malfunction
- 3,879
- Total
- 3,879
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K181865
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181865.
Data sourced from openFDA. This site is unofficial and independent of the FDA.