510(k) · Cleared
ClearedScopeSeal Duodenoscope Protective Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gi Scientific, LLC · ODB Endoscopic Contamination Prevention Sheath
Cleared on Oct 8, 2019 as substantially equivalent to K100966 (Sheathing Technologies, Inc., 2010) after a 326-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- Oct 8, 2019
- Review
- 326 days
- Class
- Class II
- Product code
- ODB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K921244 (1992). 23 ancestors in all, the oldest K822846 (1982). No later device cites it as a predicate yet.
- Root · 7 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 6 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 5 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 4 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 3 generations backK032688 Colonosight Model 510BSightline Technologies, Ltd. · 2004
- 2 generations backK081004 Protectiscope CS Colonoscope, Non-IntrapullStryker GI · 2008
- 1 generation backK100966 Colonoscope/Sigmoidoscope SheathesSheathing Technologies, Inc. · 2010
- This deviceK183171 ScopeSeal Duodenoscope Protective DeviceGi Scientific, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −6 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −5 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −4 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −3 | K032688 | Colonosight Model 510B | Sightline Technologies, Ltd. | 2004 | — |
| −2 | K081004 | Protectiscope CS Colonoscope, Non-Intrapull | Stryker GI | 2008 | — |
| −1 | K100966 | Colonoscope/Sigmoidoscope Sheathes | Sheathing Technologies, Inc. | 2010 | — |
| 0 (this device) | K183171 | ScopeSeal Duodenoscope Protective Device | Gi Scientific, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 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 ODB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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.
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?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 23 ancestors have a recall of any class.
How does its category compare?
All ODB devicesODB Endoscopic Contamination Prevention Sheath: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · ODB
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · ODB
Too few ODB 510(k)s in any year since 2007 to give a median.
Recalls per year · ODB
No recall names ODB since 2007.
Adverse event reports per year · ODB
10in 2025
MAUDE reports naming product code ODB, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
When properly installed: (i) the ScopeSeal® Duodenoscope Protective Device acts as a protective barrier at the scope’s distal end to significantly reduce the level of contamination of the distal end during use and prior to reprocessing, and (ii) the ScopeSeal®’s working channel also provides a protective barrier sealing the duodenoscope’s elevator area during use, and (iii) the ScopeSeal® device provides an additional protective benefit after use when kept in place during the ScopeSeal Pre-Cleaning Procedure™ performed after use.
The ScopeSeal® is compatible for use with the Olympus Duodenoscope Model TIF-Q180V.
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/K183171 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183171: ScopeSeal Duodenoscope Protective Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183171
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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