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.

Clearance details

Applicant: Resnent, LLC
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2024-06-17
Decision date: 2025-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IL, 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.