MONARCH Platform (MON-000008)— 510(k) K260382
Substantially EquivalentAuris Health, Inc.
FDA 510(k) clearance K260382 for MONARCH Platform (MON-000008), Substantially Equivalent on 2026-07-25. Applicant: Auris Health, Inc.. Device class: 2.
Clearance details
- Applicant
- Auris Health, Inc.
- Product code
- Code EOQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
Recent devices under product code EOQ
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- K260565 — SmartClip Delivery Catheter (ADR-1715)
- K252341 — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)
- K260420 — LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
More clearances from Auris Health, Inc.
view allAdverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
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.