# K965233: Sharpsite AC

- Pathway: 510(k) (Traditional)
- Applicant: Xomed, Inc.
- Decided: Apr 4, 1997 after 94 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
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) current Xomed endoscopes: named in the summary without a submission number
- (no number) sinuscopes currently marketed by Smith & Nephew (S&N) ENT: named in the summary without a submission number

## Most influential descendants
- K142249: Schoelly Sinuscope (2015), 3 descendants of its own
- K191102: Precision S 4K Sinuscope (2019), 2 descendants of its own
- K253602: Precision S 4K Sinuscope (2026), 0 descendants of its own
- K241731: Outlook Surgical Versa One System (8900139) (2025), 0 descendants of its own
- K173855: Sharpsite AC Rigid Endsocope (2018), 0 descendants of its own

## Indications for use
The Xomed SHARPSITE Ac rigid rod lens endoscopes are intended for use in surgical imaging in otolaryngology and Head and Neck procedures, including rhinology, and endoscopic plastic and reconstructive surgery.

Source page: https://510kreport.com/device/K965233
Methodology: https://510kreport.com/methodology