510(k) Report

510(k) · Cleared

Cleared

Oratec Ablator-S Probes (Monopolar Ablation Suction Probes)

K992805510(k) TraditionalCleared Feb 4, 2000168-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 Feb 4, 2000 as substantially equivalent to K965007 (Oratec Interventions, Inc., 1997) and 5 other predicates after a 168-day review. Its family tree reaches back 2 generations to 1995.

Decided
Feb 4, 2000
Review
168 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K943450 (1995). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 2 other ancestors1997: 1 other ancestor1996: 1 other ancestorK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995K961747 · Arthrocare Arthroscopic Electrosurgery System (Model 970) · Arthrocare Corp. · 19961996199820002002
Other ancestors, by generation 1 generation back: 4 other ancestors K961747 · Arthrocare Arthroscopic Electrosurgery System (Model 970) · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 19950
  1. Root · 2 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 1 generation backK961747 Arthrocare Arthroscopic Electrosurgery System (Model 970)Arthrocare Corp. · 1996
  3. This deviceK992805 Oratec Ablator-S Probes (Monopolar Ablation Suction Probes)Oratec Interventions, Inc. · 2000
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−1K961747Arthrocare Arthroscopic Electrosurgery System (Model 970)Arthrocare Corp.1996—
0 (this device)K992805Oratec Ablator-S Probes (Monopolar Ablation Suction Probes)Oratec Interventions, Inc.2000—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199920
FIG. 1 — Lineage of K992805, 1995–2000Source: 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
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What was it cleared against? (6)

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
*K965007Oratec Interventiouns Electrosurgical Probes
Summary page 1
…mon/usual Name: Electrosurgical accessory Proprietary Name: ORATEC® Ablator™-S Probe (Monopolar Ablation Suction Probe) Predicate Devices: ORATEC Electrosurgical Probes (K965007 and K992408) ORATEC Bipolar Ablation Suction Probes (K991218) ArthroCare Ablation Probes (K943450, K961747, and K962321) Device…
Oratec Interventions, Inc.1997—
*K992408Electrosurgical Probes Family: Ligament Chisels, Micro Ligament Chisels, Ablator Probes
Summary page 1
…me: Electrosurgical accessory Proprietary Name: ORATEC® Ablator™-S Probe (Monopolar Ablation Suction Probe) Predicate Devices: ORATEC Electrosurgical Probes (K965007 and K992408) ORATEC Bipolar Ablation Suction Probes (K991218) ArthroCare Ablation Probes (K943450, K961747, and K962321) Device Description…
Oratec Interventions, Inc.1999—
*K991218Oratec Bipolar Ablation Probes
Cleared while this submission was under review
Summary page 1
…ATEC® Ablator™-S Probe (Monopolar Ablation Suction Probe) Predicate Devices: ORATEC Electrosurgical Probes (K965007 and K992408) ORATEC Bipolar Ablation Suction Probes (K991218) ArthroCare Ablation Probes (K943450, K961747, and K962321) Device Description: The devices described in this 510(k) are sterile…
Oratec Interventions, Inc.1999—
*K943450Arthrocare Arthroscopic Electrosurgery System Model 970
Summary page 1
…ation Suction Probe) Predicate Devices: ORATEC Electrosurgical Probes (K965007 and K992408) ORATEC Bipolar Ablation Suction Probes (K991218) ArthroCare Ablation Probes (K943450, K961747, and K962321) Device Description: The devices described in this 510(k) are sterile, disposable devices designed for use…
Arthrocare Corp.1995—
*K961747Arthrocare Arthroscopic Electrosurgery System (Model 970)
Summary page 1
…tion Probe) Predicate Devices: ORATEC Electrosurgical Probes (K965007 and K992408) ORATEC Bipolar Ablation Suction Probes (K991218) ArthroCare Ablation Probes (K943450, K961747, and K962321) Device Description: The devices described in this 510(k) are sterile, disposable devices designed for use with the…
Arthrocare Corp.1996—
*K962321Arthocare Arthroscopic Electrosurgery System Model 970
Summary page 1
…redicate Devices: ORATEC Electrosurgical Probes (K965007 and K992408) ORATEC Bipolar Ablation Suction Probes (K991218) ArthroCare Ablation Probes (K943450, K961747, and K962321) Device Description: The devices described in this 510(k) are sterile, disposable devices designed for use with the ORATEC Vulca…
Arthrocare Corp.1996—

Also cleared against K965007: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 5 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
  • None of the 6 ancestors has a recall.
  • 2 other devices also cite its predicate K965007.

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® Ablator-S Probes are disposable, monopolar electrosurgical devices intended to be used for ablation, and hemostasis of soft tissues in arthroscopic procedures. They are designed to be used with the ORATEC® Vulcan™ EAS™ generator.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K965007

2 other devices cite the same predicate.

  • K992408Electrosurgical Probes Family: Ligament Chisels, Micro Ligament Chisels, Ablator ProbesOratec Interventions, Inc. · 1999
  • K991190Deflectable Electrosurgical ProbesOratec Interventions, Inc. · 1999

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
  • K994333Ora-50 Electrothermal System and AccessoriesOratec Interventions, Inc. · 2000

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The GEI category page

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https://510kreport.com/device/K992805 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992805: Oratec Ablator-S Probes (Monopolar Ablation Suction Probes).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992805

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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