Sharpsite AC Rigid Endsocope— 510(k) K173855

Substantially Equivalent

Medtronic Xomed, Inc.

FDA 510(k) clearance K173855 for Sharpsite AC Rigid Endsocope, Substantially Equivalent on 2018-04-20. Applicant: Medtronic Xomed, Inc..

Clearance details

Applicant: Medtronic Xomed, Inc.
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2017-12-20
Decision date: 2018-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOB

product code EOB

Malfunction: 6,143
Total: 6,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.