EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM— 510(k) K061899
Substantially EquivalentAdvanced Sterilization Products
FDA 510(k) clearance K061899 for EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM, Substantially Equivalent on 2006-10-26. Applicant: Advanced Sterilization Products. Device class: 2.
Clearance details
- Applicant
- Advanced Sterilization Products
- 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
view all- K234082 — STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104) +1 more
- K163598 — Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator
- K162007 — STERRAD NX Sterilizer
- K160818 — STERRAD® NX Sterilizer with ALLClear Technology
- K160903 — STERRAD 100NX Sterilizer with ALLClearTM Technology
Adverse 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.