Monarch Platform, Urology— 510(k) K213334
Substantially EquivalentAuris Health, Inc.
FDA 510(k) clearance K213334 for Monarch Platform, Urology, Substantially Equivalent on 2022-04-29. Applicant: Auris Health, Inc.. Device class: 2.
Clearance details
- Applicant
- Auris Health, Inc.
- Product code
- Code FGB
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redwood, CA, US
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- K252929 — Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)
More clearances from Auris Health, Inc.
view allAdverse events under product code FGB
product code FGB- Death
- 6
- Injury
- 552
- Malfunction
- 3,922
- Other
- 1
- Total
- 4,481
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 K213334
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213334.
Data sourced from openFDA. This site is unofficial and independent of the FDA.