Cleared Traditional

Outlook Surgical Versa One System (8900139)

K241731 · Resnent, LLC · Ear, Nose, Throat

Aug 2025

Decision

420d

Days

Class 2

Risk

About This 510(k) Submission

K241731 is an FDA 510(k) clearance for the Outlook Surgical Versa One System (8900139), a Nasopharyngoscope (flexible Or Rigid) (Class II — Special Controls, product code EOB), submitted by Resnent, LLC (Bloomington, US). The FDA issued a Cleared decision on August 11, 2025, 420 days after receiving the submission on June 17, 2024. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K241731 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 2024
Decision Date	August 11, 2025
Days to Decision	420 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	EOB — Nasopharyngoscope (flexible Or Rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4760
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).