510(k) · Cleared
Recalled · 2004Endo-Scrub/Endo-Scrub 2
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 Aug 27, 1998 as substantially equivalent to K902683 (Healthtek Microsurgical, Inc., 1990) after a 34-day review. Its family tree reaches back 1 generation to 1990. 23 later devices descend from it. It has been recalled once.
- Decided
- Aug 27, 1998
- Review
- 34 days
- Class
- Class II
- Product code
- EOB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902683 (1990). 23 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK902683 Scopescrubber (TM)Healthtek Microsurgical, Inc. · 1990
- This deviceK982594 Endo-Scrub/Endo-Scrub 2Xomed, Inc. · 1998
- Descendant · cites it directly · 16 of its ownK080613 Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008
- Descendant · 2 generations on · 8 of its ownK151117 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015
- Descendant · 3 generations on · 7 of its ownK160172 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016
- Descendant · 4 generations on · 6 of its ownK170103 Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2017
- Descendant · 5 generations on · 4 of its ownK192891 Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2019
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K080613Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008 · cites it directly16descendants
- K151117Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015 · 2 generations on8descendants
- K160172Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016 · 3 generations on7descendants
- K170103Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2017 · 4 generations on6descendants
- K192891Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2019 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902683 | Scopescrubber (TM) | Healthtek Microsurgical, Inc. | 1990 | — |
| 0 (this device) | K982594 | Endo-Scrub/Endo-Scrub 2 | Xomed, Inc. | 1998 | — |
| +1 | K080613 | Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045 | Minimally Invasive Devices, LLC | 2008 | — |
| +2 | K151117 | Laparoscope Lens Shield Device | Medeon Biodesign, Inc. | 2015 | — |
| +3 | K160172 | Laparoscope Lens Shield Device | Medeon Biodesign, Inc. | 2016 | — |
| +4 | K170103 | Laparoscope Lens Shield Device (LENS) | Medeon Biodesign, Inc. | 2017 | — |
| +5 | K192891 | Laparoscope Lens Shield Device (LENS) | Medeon Biodesign, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 5 | 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? (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 | Decided |
|---|---|---|---|
| * | K902683 | Scopescrubber (TM)Summary page 1…ebra B. Cortner Xomed Surgical Products Jacksonville, FL (904) 279-7586 Device Name Proprietary Name: Endo-Scrub/Endo-Scrub 2 (Previously known as ScopeScrubber per K902683/A) Common Name(s): Suction/Irrigation device Classification Names: Rigid sinus endoscopes (nasopharyngoscopes) and accessories D… | 1990 |
What descends from it? (23)
See all 233 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 29, 2004 | Not classified | Z-0954-04 | Other | The sheaths in question have shafts that are one inch longer than required for the endoscope specified on the label. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K080613 (Minimally Invasive Devices, LLC, 2008) has gone furthest, with 16 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 Endo-Scrub 2 is intended to clear the end of a rigid rod endoscope, in order to maintain good visualization of endoscopic procedures without having to remove the scope from the surgical site.
The device is indicated for use during routine diagnostic procedures and during endoscopic sinus surgery with standard mechanical instruments and lasers.
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/K982594 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982594: Endo-Scrub/Endo-Scrub 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982594
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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