510(k) · Cleared
ClearedORISE Tissue Retractor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Feb 9, 2018 as substantially equivalent to K153698 (Lumenr, LLC, 2016) after a 101-day review. Its family tree reaches back 3 generations to 2004. 2 later devices descend from it.
- Decided
- Feb 9, 2018
- Review
- 101 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K040836 (2004). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK040836 Disposable OvertubeUnited States Endoscopy Group, Inc. · 2004
- 2 generations backK080550 Megachannel Endoscopic Overtube, Model OT22Minos Medical · 2008
- 1 generation backK153698 LumenR Tissue Retractor SystemLumenr, LLC · 2016
- This deviceK173400 ORISE Tissue Retractor SystemBoston Scientific · 2018
- Descendant · cites it directly · 1 of its ownK182540 DiLumen Endolumenal Interventional PlatformLumendi, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK210851 DiLumen Endolumenal Interventional Platform (DiLumen)Lumendi, LLC · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K040836 | Disposable Overtube | United States Endoscopy Group, Inc. | 2004 | — |
| −2 | K080550 | Megachannel Endoscopic Overtube, Model OT22 | Minos Medical | 2008 | — |
| −1 | K153698 | LumenR Tissue Retractor System | Lumenr, LLC | 2016 | — |
| 0 (this device) | K173400 | ORISE Tissue Retractor System | Boston Scientific | 2018 | — |
| +1 | K182540 | DiLumen Endolumenal Interventional Platform | Lumendi, LLC | 2018 | — |
| +2 | K210851 | DiLumen Endolumenal Interventional Platform (DiLumen) | Lumendi, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 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 FED? 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 FED device
- #1 K241181 Disposable Ureteral Guide Sheathscore 15.0 · 5 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 |
|---|---|---|---|
| * | K153698 | LumenR Tissue Retractor SystemSummary page 4…duct Code: FED, ODB, GAD Classification: Class II 3. Predicate Device: Trade Name: LumenR Cannula Retractor System 510(k) Number: K153698 Classification Name: Endoscope and Accessories Regulation Number: 876.1500 Product Code: FED, ODB, GAD Classifi… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182540 | DiLumen Endolumenal Interventional Platform | 2018 | 1 |
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 14 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K182540 (Lumendi, LLC, 2018) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FED devicesFED Endoscopic Access Overtube, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · FED
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FED
120in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FED
4in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · FED
115in 2025
MAUDE reports naming product code FED, 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 | 1 | — | 1 | 14 |
| 2008 | 1 | — | 0 | 18 |
| 2009 | 4 | 90 | 0 | 19 |
| 2010 | 3 | 90 | 0 | 19 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 4 | 82 | 0 | 35 |
| 2013 | 2 | — | 3 | 25 |
| 2014 | 4 | 123 | 0 | 34 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 5 | 126 | 0 | 29 |
| 2017 | 1 | — | 0 | 32 |
| 2018 | 4 | 122 | 0 | 34 |
| 2019 | 5 | 94 | 0 | 30 |
| 2020 | 4 | 117 | 0 | 33 |
| 2021 | 3 | 189 | 0 | 55 |
| 2022 | 1 | — | 0 | 36 |
| 2023 | 3 | 138 | 0 | 53 |
| 2024 | 6 | 98 | 4 (4) | 64 |
| 2025 | 11 | 120 | 0 | 115 |
| 2026 | 6 | 67 | 0 | — |
What is it indicated for?
This device is indicated for use in conjunction with an endoscope in the gastrointestinal tract for tissue or foreign body manipulation and/or where multiple removal and insertions of an endoscope are required.
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/K173400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173400: ORISE Tissue Retractor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173400
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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