510(k) · Cleared
ClearedPercscope Model 2600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clarus Medical Systems, Inc. · HRX Arthroscope
Cleared on Feb 18, 1998 as substantially equivalent to K941188 (Clarus Medical Systems, Inc., 1995) after a 72-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Feb 18, 1998
- Review
- 72 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K941188 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK941188 Clarus Neuro Endoscope (Model 2230)Clarus Medical Systems, Inc. · 1995
- This deviceK974579 Percscope Model 2600Clarus Medical Systems, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK240535 Digital ClarusScope System; Digital NeuroPEN SystemClarus Medical, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K240535Digital ClarusScope System; Digital NeuroPEN SystemClarus Medical, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941188 | Clarus Neuro Endoscope (Model 2230) | Clarus Medical Systems, Inc. | 1995 | — |
| 0 (this device) | K974579 | Percscope Model 2600 | Clarus Medical Systems, Inc. | 1998 | — |
| +1 | K240535 | Digital ClarusScope System; Digital NeuroPEN System | Clarus Medical, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 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? (3)
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 |
|---|---|---|---|
| * | K941188 | Clarus Neuro Endoscope (Model 2230)Summary page 5…as as irrigation channel for sterile fluid flush or aspiration. The Model 2600 Neuro Endoscope is a modification of the current Model 2230 Neuro Endoscope filled under K941188. The Model 2600 incoy;at_es similar materials and design of the Model 2230 and the originai Series 2200 Semi-rigid Endoscopes, as… | 1995 |
| Kept off the family tree | K922281 | FDA’s K922281 is Illuminator Vii Mini/Spot Light Our OCR of the scanned summary read K922281, FDA’s number for Illuminator Vii Mini/Spot Light (Medical Illumination, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Model 2125 Endoscopic Ball Probe”. Kept off the family tree. Summary page 5…e gained either during an open operative procedure or percutaneously. Access during an open procedure would be the same as with the Clarus Endoscopic Ball Probe filed as K922281. The percutaneous access procedure is identical to the disc access procedure used for the Model 2230. The instrumentation and tec… | 1993 |
| * | — | Model 1103 Laser Endoscopic Disc Decompression Kit Named without a submission number | |
| † | K924554 | Clarus Serirs 2200 Semi-Rigid Endoscope | 1993 |
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 |
|---|---|---|---|
| K240535 | Digital ClarusScope System; Digital NeuroPEN System | 2024 | 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?
- Its one ancestor has no recall.
- Of its descendants, K240535 (Clarus Medical, LLC, 2024) has gone furthest, with 0 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 2600 endoscope is intended for accessing and visualizing the spinal nerve roots, foramina, intervertebral disc, and the surrounding tissues of the lumbar spine. The endoscope has a working channel intended for the passage of surgical instruments indicated for use in this area. Surgical instrumentation may be used for discectomy procedures, bone, and osteophyte removal, procedures associated with ruptured or herniated discs such as, retrieval of extruded disc fragments and retrieval of free fragments. The Model 2600 also has as irrigation channel for sterile fluid flush or aspiration.
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/K974579 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974579: Percscope Model 2600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974579
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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