AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor— 510(k) K181472
Substantially EquivalentAdvanced Sterilization Products (Asp)
FDA 510(k) clearance K181472 for AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor, Substantially Equivalent on 2019-04-23. Applicant: Advanced Sterilization Products (Asp). Device class: 2.
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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvin, CA, 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 Advanced Sterilization Products (Asp)
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.