EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR— 510(k) K082392
Substantially EquivalentAdvanced Sterilization Products
FDA 510(k) clearance K082392 for EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR, Substantially Equivalent on 2008-11-13. 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
- Special
- 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 →
Recalls naming K082392
K-number listed on FDA's recall record- 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.
- Z-1150-2013 — EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
- Z-1123-2013 — EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082392.
Data sourced from openFDA. This site is unofficial and independent of the FDA.