510(k) · Cleared
ClearedYeung Endoscopic Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · HRX Arthroscope
Cleared on Mar 13, 1998 after a 185-day review. The summary cites 2 numbers, none of which could be confirmed as its predicate (see the table below). 29 later devices descend from it.
- Decided
- Mar 13, 1998
- Review
- 185 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
29 later devices descend from it, 6 citing it directly.
- This deviceK973405 Yeung Endoscopic Spine SystemRichard Wolf Medical Instruments Corp. · 1998
- Descendant · cites it directly · 20 of its ownK082841 Spinal ForaminoscopeBlazejewski Medi-Tech GmbH · 2009
- Descendant · 2 generations on · 14 of its ownK130778 Discoscopes, Cervical EndoscopesRz Medizintechnik GmbH · 2014
- Descendant · 3 generations on · 12 of its ownK180766 Endiscope, Endiscope CervicalElliquence, LLC · 2018
- Descendant · 4 generations on · 11 of its ownK201134 Arthrex NanoScope SystemArthrex, Inc. · 2020
- Descendant · cites it directly · 5 of its ownK083552 Maxmorespine Tom StickHoogland Spine Products, GmbH · 2009
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K082841Spinal ForaminoscopeBlazejewski Medi-Tech GmbH · 2009 · cites it directly20descendants
- K130778Discoscopes, Cervical EndoscopesRz Medizintechnik GmbH · 2014 · 2 generations on14descendants
- K180766Endiscope, Endiscope CervicalElliquence, LLC · 2018 · 3 generations on12descendants
- K201134Arthrex NanoScope SystemArthrex, Inc. · 2020 · 4 generations on11descendants
- K083552Maxmorespine Tom StickHoogland Spine Products, GmbH · 2009 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973405 | Yeung Endoscopic Spine System | Richard Wolf Medical Instruments Corp. | 1998 | — |
| +1 | K082841 | Spinal Foraminoscope | Blazejewski Medi-Tech GmbH | 2009 | — |
| +2 | K130778 | Discoscopes, Cervical Endoscopes | Rz Medizintechnik GmbH | 2014 | — |
| +3 | K180766 | Endiscope, Endiscope Cervical | Elliquence, LLC | 2018 | — |
| +4 | K201134 | Arthrex NanoScope System | Arthrex, Inc. | 2020 | — |
| +1 | K083552 | Maxmorespine Tom Stick | Hoogland Spine Products, GmbH | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 0 |
| 2026 | 3 | 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K931911 | FDA’s K931911 is Brillenerzeugung Pomberger or Multiple Spec Frames Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1993 |
| Kept off the family tree | K922519 | FDA’s K922519 is Mod. Percutaneous Arthroscopic Micro Discectomy Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1994 |
| * | — | Richard Wolf 8986.401 Operative Scope Named without a submission number | |
| * | — | Sofamor Danek MED Endoscope Named without a submission number | |
| * | — | Smith & Nephew Richards AMD VideoDiscoscope Named without a submission number |
What descends from it? (29)
See all 296 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082841 | Spinal Foraminoscope | 2009 | 20 |
| K083552 | Maxmorespine Tom Stick | 2009 | 5 |
| K141326 | Needle View CH Scope Kits | 2014 | 3 |
| K994363 | Instruments for Minimally Invasive Spinal Surgery (Miss) | 2000 | 2 |
| K090132 | Maxmorespine Spinal System | 2009 | 1 |
| K022198 | Endoscope Set for Magnetic Resonance (MR), Models 8767.412, 8767.121 & 8767.452 | 2003 | 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?
- Of its descendants, K082841 (Blazejewski Medi-Tech GmbH, 2009) has gone furthest, with 20 descendants of its own.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Yeung Endoscopic Spine System is indicated for the visualization and removal of herniated discs in the lumbar region.
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/K973405 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973405: Yeung Endoscopic Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973405
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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