510(k) · Cleared
ClearedEndiscope, Endiscope Cervical
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elliquence, LLC · HRX Arthroscope
Cleared on Jun 11, 2018 as substantially equivalent to K130778 (Rz Medizintechnik GmbH, 2014) after an 80-day review. Its family tree reaches back 3 generations to 1995. 12 later devices descend from it.
- Decided
- Jun 11, 2018
- Review
- 80 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953484 (1995). 6 ancestors in all. 12 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK953484 Pollux OA/Pollux 30A/Pollux 70APollux Endoscopy, Inc. · 1995
- 2 generations backK082841 Spinal ForaminoscopeBlazejewski Medi-Tech GmbH · 2009
- 1 generation backK130778 Discoscopes, Cervical EndoscopesRz Medizintechnik GmbH · 2014
- This deviceK180766 Endiscope, Endiscope CervicalElliquence, LLC · 2018
- Descendant · cites it directly · 11 of its ownK201134 Arthrex NanoScope SystemArthrex, Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK243008 Arthrex NanoScope SystemArthrex, Inc. · 2025
- Descendant · 2 generations on · 4 of its ownK223759 Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc. · 2023
- Descendant · 3 generations on · 3 of its ownK233451 Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc. · 2024
- Descendant · 4 generations on · 2 of its ownK241361 Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc. · 2024
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K201134Arthrex NanoScope SystemArthrex, Inc. · 2020 · cites it directly11descendants
- K243008Arthrex NanoScope SystemArthrex, Inc. · 2025 · 2 generations on4descendants
- K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc. · 2023 · 2 generations on4descendants
- K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc. · 2024 · 3 generations on3descendants
- K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc. · 2024 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953484 | Pollux OA/Pollux 30A/Pollux 70A | Pollux Endoscopy, Inc. | 1995 | — |
| −2 | K082841 | Spinal Foraminoscope | Blazejewski Medi-Tech GmbH | 2009 | — |
| −1 | K130778 | Discoscopes, Cervical Endoscopes | Rz Medizintechnik GmbH | 2014 | — |
| 0 (this device) | K180766 | Endiscope, Endiscope Cervical | Elliquence, LLC | 2018 | — |
| +1 | K201134 | Arthrex NanoScope System | Arthrex, Inc. | 2020 | — |
| +2 | K243008 | Arthrex NanoScope System | Arthrex, Inc. | 2025 | — |
| +2 | K223759 | Arthrex SynergyID Endoscopic Imaging System | Arthex, Inc. | 2023 | — |
| +3 | K233451 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | 2024 | — |
| +4 | K241361 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 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 |
|---|---|---|---|
| * | K130778 | Discoscopes, Cervical EndoscopesSummary page 4…lass II FDA Product Code: HRX Predicate Devices (807.92(a)(3)) Predicate Device 510(k) Number 510(k) Holder Discoscopes, Cervical K130778 RZ Medizintechnik Endoscopes… | 2014 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201134 | Arthrex NanoScope System | 2020 | 11 |
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 23 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K201134 (Arthrex, Inc., 2020) has gone furthest, with 11 descendants of its own.
- 1 other device also cites its predicate K130778.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
Elliquence endoscopes are indicated for visualization of the intraoperative site during spinal endoscopic procedures and minimally invasive 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/K180766 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180766: Endiscope, Endiscope Cervical.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180766
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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