AMSCO V-PRO— 510(k) K112813
Substantially EquivalentSteris Corp
FDA 510(k) clearance K112813 for AMSCO V-PRO, Substantially Equivalent on 2011-12-01. Applicant: Steris Corp. Device class: 2.
Clearance details
- Applicant
- Steris Corp
- Product code
- Code MLR
- Device class
- Class 2
- Regulation
- 21 CFR 880.6860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mentor, OH, US
Recent devices under product code MLR
view all- K252843 — STERRAD 100NX Sterilization System with ALLClear Technology (10104)
- K250802 — STERRAD® 100NX Sterilizer with ALLClear Technology (10104)
- K231893 — LOWTEM Crystal 120
- K234082 — STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104) +1 more
- K233762 — SteroScope® Sterilization Technology System
Adverse events under product code MLR
product code MLR- Malfunction
- 805
- Total
- 805
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.