510(k) · Cleared
ClearedSharpsite AC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xomed, Inc. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Apr 4, 1997 after a 94-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Apr 4, 1997
- Review
- 94 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK965233 Sharpsite ACXomed, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK142249 Schoelly SinuscopeSchoelly Fiberoptic GmbH · 2015
- Descendant · 2 generations on · 2 of its ownK191102 Precision S 4K SinuscopeStryker · 2019
- Descendant · 3 generations on · 0 of its ownK253602 Precision S 4K SinuscopeStryker Endoscopy · 2026
- Descendant · 3 generations on · 0 of its ownK241731 Outlook Surgical Versa One System (8900139)Resnent, LLC · 2025
- Descendant · cites it directly · 0 of its ownK173855 Sharpsite AC Rigid EndsocopeMedtronic Xomed, Inc. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K142249Schoelly SinuscopeSchoelly Fiberoptic GmbH · 2015 · cites it directly3descendants
- K191102Precision S 4K SinuscopeStryker · 2019 · 2 generations on2descendants
- K253602Precision S 4K SinuscopeStryker Endoscopy · 2026 · 3 generations on0descendants
- K241731Outlook Surgical Versa One System (8900139)Resnent, LLC · 2025 · 3 generations on0descendants
- K173855Sharpsite AC Rigid EndsocopeMedtronic Xomed, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K965233 | Sharpsite AC | Xomed, Inc. | 1997 | — |
| +1 | K142249 | Schoelly Sinuscope | Schoelly Fiberoptic GmbH | 2015 | — |
| +2 | K191102 | Precision S 4K Sinuscope | Stryker | 2019 | — |
| +3 | K253602 | Precision S 4K Sinuscope | Stryker Endoscopy | 2026 | — |
| +3 | K241731 | Outlook Surgical Versa One System (8900139) | Resnent, LLC | 2025 | — |
| +1 | K173855 | Sharpsite AC Rigid Endsocope | Medtronic Xomed, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | — | current Xomed endoscopes Named without a submission number | |
| * | — | sinuscopes currently marketed by Smith & Nephew (S&N) ENT Named without a submission number |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K142249 (Schoelly Fiberoptic GmbH, 2015) has gone furthest, with 3 descendants of its own.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EOB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOB
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EOB
1,338in 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?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K965233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K965233: Sharpsite AC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K965233
Report an extraction error
Are you the manufacturer?
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