# K241731: Outlook Surgical Versa One System (8900139)

- Pathway: 510(k) (Traditional)
- Applicant: Resnent, LLC
- Decided: Aug 11, 2025 after 420 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K965233 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191102: Precision S 4K Sinuscope, Stryker (2019) Summary page 5.

## Indications for use
The Outlook Surgical Versa One System is intended for use in examination and visualization in otolaryngology and head and neck procedures.

Source page: https://510kreport.com/device/K241731
Methodology: https://510kreport.com/methodology