510(k) · Cleared

Cleared

Sharpsite AC Rigid Endsocope

K173855510(k) TraditionalCleared Apr 20, 2018121-day reviewClass II21 CFR 874.4760

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Xomed, Inc. · EOB Nasopharyngoscope (Flexible Or Rigid)

Cleared on Apr 20, 2018 as substantially equivalent to K965233 (Xomed, Inc., 1997) after a 121-day review. Its family tree reaches back 1 generation to 1997.

Decided: Apr 20, 2018
Review: 121 days
Class: Class II
Product code: EOB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K965233 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK965233 Sharpsite ACXomed, Inc. · 1997
This deviceK173855 Sharpsite AC Rigid EndsocopeMedtronic Xomed, Inc. · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K965233	Sharpsite AC	Xomed, Inc.	1997	—
0 (this device)	K173855	Sharpsite AC Rigid Endsocope	Medtronic Xomed, Inc.	2018	—

FIG. 1 — Lineage of K173855, 1997–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EOB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new EOB device

#1 K253184 Video Rhinolaryngoscope System (Disposable…score 14.4 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K965233	Sharpsite AC Summary page 5 …oscopes are manufactured in multiple configurations that differ in insertion tube outer diameter and optical parameters. These endoscopes were previously cleared by FDA (K965233) for the visualization during otolaryngology and head and neck procedures. Sharpsite™ AC Endoscope Sterilization Tray Sharpsite™…	Xomed, Inc.	1997	—

Also cleared against K965233: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
2 other devices also cite its predicate K965233.

How does its category compare?

All EOB devices

EOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · EOB

3in 2025

2007high 8 (2019) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EOB

192in 2025

2007high 282 (2014) · low 37 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EOB

1in 2023

2007high 2 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EOB

1,338in 2025

2007high 1,498 (2024) · low 0 (2010)2025

MAUDE reports naming product code EOB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	4	37	0	1
2008	4	38	0	1
2009	1	—	0	3
2010	1	—	0	0
2011	4	209	2	3
2012	1	—	0	4
2013	0	—	0	5
2014	3	282	0	5
2015	3	115	0	13
2016	3	174	0	16
2017	6	216	0	18
2018	6	230	0	23
2019	8	149	0	51
2020	3	175	0	47
2021	2	—	0	345
2022	6	178	1	1,158
2023	3	107	1	1,352
2024	2	—	0	1,498
2025	3	192	0	1,338
2026	5	180	1	—

What is it indicated for?

Sharpsite™ AC Rigid Endoscope: The Sharpsite™ AC Rigid Endoscopes are intended for use in surgical imaging in otolaryngology and Head and Neck procedures, including rhinology and endoscopic plastic and reconstructive surgery.

Sharpsite™ AC Sterilization Tray: Sharpsite™ AC Endoscope Sterilization Tray is intended to provide a specific configuration to hold, organize and protect Sharpsite™ AC Rigid Endoscope during their transport, storage and sterilization prior to use in surgical procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K173855 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173855: Sharpsite AC Rigid Endsocope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173855

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026