DeviceClearance

Outlook Surgical Versa One System (8900139)— 510(k) K241731

Substantially Equivalent

Resnent, LLC

FDA 510(k) clearance K241731 for Outlook Surgical Versa One System (8900139), Substantially Equivalent on 2025-08-11. Applicant: Resnent, LLC. Device class: 2.

Clearance details

Applicant
Resnent, LLC
Product code
Code EOB
Device class
Class 2
Regulation
21 CFR 874.4760
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bloomington, IL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code EOB

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Adverse events under product code EOB

product code EOB
Malfunction
6,143
Total
6,143

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.