Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Outlook Surgical Versa One System (8900139)

K-Number: K241731 · 2025-08-11

ApplicantResnent, LLC
Decision Date2025-08-11
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Outlook Surgical Versa One System (8900139) is the device name listed in this FDA 510(k) record. The listed applicant is Resnent, LLC. It received FDA 510(k) clearance on 2025-08-11 under 510(k) number K241731. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Outlook Surgical Versa One System (8900139)?

Outlook Surgical Versa One System (8900139) is a medical device that received FDA 510(k) clearance on 2025-08-11. The listed applicant is Resnent, LLC. The 510(k) number is K241731.

When did Outlook Surgical Versa One System (8900139) receive FDA 510(k) clearance?

Outlook Surgical Versa One System (8900139) received FDA 510(k) clearance on 2025-08-11, under 510(k) number K241731.

Who is the listed applicant for Outlook Surgical Versa One System (8900139)?

The FDA 510(k) record lists Resnent, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Outlook Surgical Versa One System (8900139)?

The FDA product code for Outlook Surgical Versa One System (8900139) is EOB.

Related Devices (Code: EOB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261544Hydro Irrigation SystemStryker InstrumentsK254133ENTity USB Videoscope SystemOptim, LLCK253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd.K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems CorporationK243639Portare System (FA-001)Grumpy Innovation, Inc.K243380VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)Olympus Medical Systems Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑