SteroScope® Sterilization Technology System— 510(k) K233762
Substantially EquivalentIdeate Medical, Inc.
FDA 510(k) clearance K233762 for SteroScope® Sterilization Technology System, Substantially Equivalent on 2024-06-27. Applicant: Ideate Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Ideate Medical, Inc.
- 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
- Traditional
- Location
- St. Louis, MO, 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
- K233065 — V-PRO maX 2 Low Temperature Sterilization 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.