510(k) · Cleared
ClearedDiLumen Endolumenal Interventional Scissors (DiLumen Is)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumendi, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 22, 2018 as substantially equivalent to K061425 (Cambridge Endoscopic Devices, 2006) after a 203-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it.
- Decided
- May 22, 2018
- Review
- 203 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K910831 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK910831 Endopath Surgical InstrumentsSymbiosis Corp. · 1991
- 2 generations backK984240 Endopath Endoscopic InstrumentsEthicon Endo-Surgery, Inc. · 1999 · Recalled
- 1 generation backK061425 Purewrist Scissors, Model PW1101-01;Purewrist Dissector, Model…Cambridge Endoscopic Devices · 2006 · Recalled
- This deviceK173405 DiLumen Endolumenal Interventional Scissors (DiLumen Is)Lumendi, LLC · 2018
- Descendant · cites it directly · 0 of its ownK183112 DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)Lumendi, LLC · 2019
Most influential descendants
Showing 1 of 1 · See all- K183112DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)Lumendi, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910831 | Endopath Surgical Instruments | Symbiosis Corp. | 1991 | — |
| −2 | K984240 | Endopath Endoscopic Instruments | Ethicon Endo-Surgery, Inc. | 1999 | 1 |
| −1 | K061425 | Purewrist Scissors, Model PW1101-01;Purewrist Dissector, Model… | Cambridge Endoscopic Devices | 2006 | 2 |
| 0 (this device) | K173405 | DiLumen Endolumenal Interventional Scissors (DiLumen Is) | Lumendi, LLC | 2018 | — |
| +1 | K183112 | DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) | Lumendi, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K061425 | Purewrist Scissors, Model PW1101-01;Purewrist Dissector, Model PW1201-01;Purewrist Hook…Summary page 4…ation device and accessories Product Code: GEI Device Class: II Predicate Device: Cambridge Endoscopic Devices, Inc. pureWrist™ electrocautery laparoscopic instruments (K061425) Reference Device: Sumitomo Bakelite Co., Ltd. SB Knife (K152771) Device Description: The DiLumen Is is a sterile, single patie… | 2006 |
| † | K152771 | SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183112 | DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) | 2019 | 0 |
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 4 companies; a new generation was cleared every 8.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K183112 (Lumendi, LLC, 2019) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K061425.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The DiLumen Endolumenal Interventional Scissors (“DiLumen Is™”) is a disposable monopolar electrosurgical device intended to be used for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173405: DiLumen Endolumenal Interventional Scissors (DiLumen Is).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173405
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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