DeviceClearance

Monarch Endoscopy Platform (Monarch Platform)— 510(k) K173760

Substantially Equivalent

Auris Surgical Robotics, Inc.

FDA 510(k) clearance K173760 for Monarch Endoscopy Platform (Monarch Platform), Substantially Equivalent on 2018-03-22. Applicant: Auris Surgical Robotics, Inc.. Device class: 2.

Clearance details

Applicant
Auris Surgical Robotics, 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
San Carlos, CA, US
Download summary PDFView on FDA.gov ↗

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More clearances from Auris Surgical Robotics, Inc.

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Adverse 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 →

Recalls naming K173760

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173760.

Data sourced from openFDA. This site is unofficial and independent of the FDA.