510(k) Report

510(k) · Cleared

Cleared

Oratec Spinecath Intradiscal Catheter

K974464510(k) TraditionalCleared Mar 19, 1998113-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Oratec Interventions, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Mar 19, 1998 as substantially equivalent to K972358 (Oratec Interventions, Inc., 1998) and 4 other predicates after a 113-day review. Its family tree reaches back 1 generation to 1990. 20 later devices descend from it.

Decided
Mar 19, 1998
Review
113 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K896183 (1990). 5 ancestors in all. 20 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1991: 1 other ancestor1999: 2 descendants cleared2006: 1 descendant cleared2004: 1 descendant cleared2002: 1 descendant cleared2007: 2 descendants cleared2008: 1 descendant cleared2013: 1 descendant cleared2016: 3 descendants cleared2017: 2 descendants cleared2018: 1 descendant cleared2023: 2 descendants cleared2025: 1 descendant cleared2026: 2 descendants clearedK896183 · KTP/532 Surgical Laser for Percutaneous Diskectomy · Laserscope · 19901990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 3 descendants4 generations forward: 4 descendants5 generations forward: 3 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant K896183 · KTP/532 Surgical Laser for Percutaneous Diskectomy · Laserscope · 19900+5
  1. Root · 1 generation backK896183 KTP/532 Surgical Laser for Percutaneous DiskectomyLaserscope · 1990
  2. This deviceK974464 Oratec Spinecath Intradiscal CatheterOratec Interventions, Inc. · 1998
  3. Descendant · cites it directly · 16 of its ownK993854 Ora-50 S Autotemp Electrothermal Spine System and AccessoriesOratec Interventions, Inc. · 1999
  4. Descendant · 2 generations on · 14 of its ownK033981 Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975Smith & Nephew, Inc. · 2004
  5. Descendant · 3 generations on · 11 of its ownK130689 Symphony RF GeneratorThermigen, Inc. · 2013
  6. Descendant · 4 generations on · 6 of its ownK171094 Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C · 2017
  7. Descendant · 5 generations on · 3 of its ownK222260 Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400…Capenergy Medical S.L. · 2023

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

1999: 22002: 12004: 12006: 12007: 22008: 12013: 12016: 32017: 22018: 12023: 22025: 12026: 2
1999high 3 (2016) · low 0 (2000)2026

Most influential descendants

Showing 5 of 20 · See all
  • K993854Ora-50 S Autotemp Electrothermal Spine System and AccessoriesOratec Interventions, Inc. · 1999 · cites it directly16descendants
  • K033981Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975Smith & Nephew, Inc. · 2004 · 2 generations on14descendants
  • K130689Symphony RF GeneratorThermigen, Inc. · 2013 · 3 generations on11descendants
  • K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C · 2017 · 4 generations on6descendants
  • K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L. · 2023 · 5 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K896183KTP/532 Surgical Laser for Percutaneous DiskectomyLaserscope1990—
0 (this device)K974464Oratec Spinecath Intradiscal CatheterOratec Interventions, Inc.1998—
+1K993854Ora-50 S Autotemp Electrothermal Spine System and AccessoriesOratec Interventions, Inc.1999—
+2K033981Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975Smith & Nephew, Inc.2004—
+3K130689Symphony RF GeneratorThermigen, Inc.2013—
+4K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C2017—
+5K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199410
199510
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
200210
200410
200610
200720
200810
201310
201630
201720
201810
202320
202510
202620
FIG. 1 — Lineage of K974464, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K972358Oratec Model Endotac Probe
Cleared while this submission was under review
Summary page 1
…h the Oratec generator. Substantial Equivalence The SpineCATH Intradiscal Catheter is substantially equivalent in design to the Oratec EndoTAC Monopolar Cautery Probe (K972358). The intended use of the SpineCATH Intradiscal Catheter, decompression of intervertebral discs, is substantially equivalent to c…
Oratec Interventions, Inc.1998—
*K931109Nucleotome E Kit
Summary page 2
…hanical and laser devices, 2-2 510(k) Premarket Notification Submission Oratec SpineCATH Intradiscal Catheter including Surgical Dynamics’ Nucleotomes (K931109, K942987) and Laserscope’s KTP/532 and KTP/Y AG Laser Systems (K896183, K913758). Biocompatibility The SpineCATH Intradiscal Ca…
Surgical Dynamics, Inc.1994—
*K942987Nucleotome L Kit
Summary page 2
…nd laser devices, 2-2 510(k) Premarket Notification Submission Oratec SpineCATH Intradiscal Catheter including Surgical Dynamics’ Nucleotomes (K931109, K942987) and Laserscope’s KTP/532 and KTP/Y AG Laser Systems (K896183, K913758). Biocompatibility The SpineCATH Intradiscal Catheter me…
Surgical Dynamics, Inc.1995—
*K896183KTP/532 Surgical Laser for Percutaneous Diskectomy
Summary page 2
…cation Submission Oratec SpineCATH Intradiscal Catheter including Surgical Dynamics’ Nucleotomes (K931109, K942987) and Laserscope’s KTP/532 and KTP/Y AG Laser Systems (K896183, K913758). Biocompatibility The SpineCATH Intradiscal Catheter meets the requirements of ISO 10993 for Limited Contact, Externa…
Laserscope1990—
*K913758KTP/532 and KTP/Yag
Summary page 2
…bmission Oratec SpineCATH Intradiscal Catheter including Surgical Dynamics’ Nucleotomes (K931109, K942987) and Laserscope’s KTP/532 and KTP/Y AG Laser Systems (K896183, K913758). Biocompatibility The SpineCATH Intradiscal Catheter meets the requirements of ISO 10993 for Limited Contact, External Communi…
Laserscope1991—

What descends from it? (20)

See all 20

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K993854Ora-50 S Autotemp Electrothermal Spine System and AccessoriesOratec Interventions, Inc.199916
K993967Oratec Spinecath Intradiscal Catheter, Model 920002Oratec Interventions, Inc.19993
K060346Ultrazonix Spine Minimal-Invasive Disc SystemUltrazonix Dnt AB20060

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?

  • None of the 5 ancestors has a recall.
  • Of its descendants, K993854 (Oratec Interventions, Inc., 1999) has gone furthest, with 16 descendants of its own.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The Oratec SpineCATH Intradiscal Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of 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.

More from Oratec Interventions, Inc.

24 FDA decisions under this applicant name. See the company

  • K013622Nucleotomy Intradiscal CatheterOratec Interventions, Inc. · 2002
  • K003198Vulcan Tac Probes, Model 911XXXOratec Interventions, Inc. · 2001
  • K003893Vulcan Ablator Electrosurgical Probes, Vulcan Ligament Chisel Electrosurgical Probes, Model…Oratec Interventions, Inc. · 2001
  • K000691Vulcan Electrosurgical Probes: Vulcan Micro Ligament Chisels, Vulcan Ligament Chisels, Vulcan Eflex Ligament…Oratec Interventions, Inc. · 2000
  • K992805Oratec Ablator-S Probes (Monopolar Ablation Suction Probes)Oratec Interventions, Inc. · 2000

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https://510kreport.com/device/K974464 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974464: Oratec Spinecath Intradiscal Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974464

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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