510(k) · Cleared
ClearedAblator Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · HRX Arthroscope
Cleared on Mar 23, 1999 after a 155-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Mar 23, 1999
- Review
- 155 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK983652 Ablator ElectrodeLinvatec Corp. · 1999
- Descendant · cites it directly · 6 of its ownK993885 Ultrablator ElectrodeLinvatec Corp. · 2000
- Descendant · 2 generations on · 4 of its ownK030720 Ultrablator ElectrodeLinvatec Corp. · 2003
- Descendant · cites it directly · 2 of its ownK050923 Lightwave Integrated Electrode Ablator and Light Wave Integrated…Conmed Linvatec · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK101711 Ceruleau Electrosurgical ProbeNuortho Surgical, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK083281 EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction…Linvatec Corp. · 2009
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K993885Ultrablator ElectrodeLinvatec Corp. · 2000 · cites it directly6descendants
- K030720Ultrablator ElectrodeLinvatec Corp. · 2003 · 2 generations on4descendants
- K050923Lightwave Integrated Electrode Ablator and Light Wave Integrated Electrode Suction AblatorConmed Linvatec · 2005 · cites it directly2descendants
- K101711Ceruleau Electrosurgical ProbeNuortho Surgical, Inc. · 2010 · 2 generations on0descendants
- K083281EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator, Model…Linvatec Corp. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983652 | Ablator Electrode | Linvatec Corp. | 1999 | — |
| +1 | K993885 | Ultrablator Electrode | Linvatec Corp. | 2000 | — |
| +2 | K030720 | Ultrablator Electrode | Linvatec Corp. | 2003 | — |
| +1 | K050923 | Lightwave Integrated Electrode Ablator and Light Wave Integrated Electrode… | Conmed Linvatec | 2005 | 1 |
| +2 | K101711 | Ceruleau Electrosurgical Probe | Nuortho Surgical, Inc. | 2010 | — |
| +2 | K083281 | EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator… | Linvatec Corp. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | ESA Electrodes Named without a submission number | |
| * | — | ArthroCare® Electrosurgery System 2000 Named without a submission number | |
| * | — | VAPR™ Named without a submission number |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K993885 (Linvatec Corp., 2000) has gone furthest, with 6 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 Ablator Electrode is designed for general surgical use, including orthopaedic and arthroscopic applications of resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues. Arthroscopic surgery includes the following: Knee Meniscectony Lateral Release Chondroplasty Synovectomy ACL Debridement Plica Removal Meniscal Cystectomy Ankle 1. Fracture Debridement 2. Excision of scar tissue 3. Synovectomy 4.…
Read the full statement (92 words)
The Ablator Electrode is designed for general surgical use, including orthopaedic and arthroscopic applications of resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues. Arthroscopic surgery includes the following:
Knee
Meniscectony
Lateral Release
Chondroplasty
Synovectomy
ACL Debridement
Plica Removal
Meniscal Cystectomy
Ankle
1. Fracture Debridement
2. Excision of scar tissue
3. Synovectomy
4. Chondroplasty
Wrist
1. Synovectomy
2. Cartilage Debridement
3. Fracture Debridement
Shoulder
3. Excision of Scar Tissue
4. Acromioplasty
5. Bursectomy
6. Subacromial Decompression
7. Chondroplasty
Elbow
1. Synovectomy
2. Tendon Debridement
3. Chondroplasty
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/K983652 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983652: Ablator Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983652
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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