510(k) · Cleared
ClearedNucleotomy Intradiscal Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oratec Interventions, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 31, 2002 as substantially equivalent to K993967 (Oratec Interventions, Inc., 1999) after an 87-day review. Its family tree reaches back 3 generations to 1990. 1 later device descends from it.
- Decided
- Jan 31, 2002
- Review
- 87 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K896183 (1990). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK896183 KTP/532 Surgical Laser for Percutaneous DiskectomyLaserscope · 1990
- 2 generations backK974464 Oratec Spinecath Intradiscal CatheterOratec Interventions, Inc. · 1998
- 1 generation backK993967 Oratec Spinecath Intradiscal Catheter, Model 920002Oratec Interventions, Inc. · 1999
- This deviceK013622 Nucleotomy Intradiscal CatheterOratec Interventions, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK073466 Smith & Nephew Intradiscal Catheter SystemSmith & Nephew, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K073466Smith & Nephew Intradiscal Catheter SystemSmith & Nephew, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K896183 | KTP/532 Surgical Laser for Percutaneous Diskectomy | Laserscope | 1990 | — |
| −2 | K974464 | Oratec Spinecath Intradiscal Catheter | Oratec Interventions, Inc. | 1998 | — |
| −1 | K993967 | Oratec Spinecath Intradiscal Catheter, Model 920002 | Oratec Interventions, Inc. | 1999 | — |
| 0 (this device) | K013622 | Nucleotomy Intradiscal Catheter | Oratec Interventions, Inc. | 2002 | — |
| +1 | K073466 | Smith & Nephew Intradiscal Catheter System | Smith & Nephew, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K993967 | Oratec Spinecath Intradiscal Catheter, Model 920002Summary page 1…d for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. Predicate Device: SpineCATH Intradiscal Catheter K993967, cleared December 28, 1999 Safety and Performance Performance and biocompatibility testing were conducted to support this claim… | 1999 |
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 |
|---|---|---|---|
| K073466 | Smith & Nephew Intradiscal Catheter System | 2008 | 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 12 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K073466 (Smith & Nephew, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K993967.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Nucleotomy Catheter is intended to be used for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs.
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/K013622 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013622: Nucleotomy Intradiscal Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013622
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026