510(k) · Cleared
ClearedUltrablator Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · JOS Electrode, Electrosurgical
Cleared on Feb 10, 2000 as substantially equivalent to K983652 (Linvatec Corp., 1999) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 1995. 6 later devices descend from it.
- Decided
- Feb 10, 2000
- Review
- 86 days
- Class
- Class II
- Product code
- JOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K944992 (1995). 2 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK944992 ElectrodesLinvatec Corp. · 1995
- This deviceK993885 Ultrablator ElectrodeLinvatec Corp. · 2000
- Descendant · cites it directly · 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 · cites it directly · 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
- Descendant · 2 generations on · 0 of its ownK052692 Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K030720Ultrablator ElectrodeLinvatec Corp. · 2003 · cites it directly4descendants
- K050923Lightwave Integrated Electrode Ablator and Light Wave Integrated Electrode Suction AblatorConmed Linvatec · 2005 · cites it directly2descendants
- K101711Ceruleau Electrosurgical ProbeNuortho Surgical, Inc. · 2010 · cites it directly0descendants
- K083281EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator, Model…Linvatec Corp. · 2009 · 2 generations on0descendants
- K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944992 | Electrodes | Linvatec Corp. | 1995 | — |
| 0 (this device) | K993885 | Ultrablator Electrode | Linvatec Corp. | 2000 | — |
| +1 | K030720 | Ultrablator Electrode | Linvatec Corp. | 2003 | — |
| +1 | K050923 | Lightwave Integrated Electrode Ablator and Light Wave Integrated Electrode… | Conmed Linvatec | 2005 | 1 |
| +1 | K101711 | Ceruleau Electrosurgical Probe | Nuortho Surgical, Inc. | 2010 | — |
| +2 | K083281 | EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator… | Linvatec Corp. | 2009 | — |
| +2 | K052692 | Suretek Medical Reprocessed Electrosurgical Electrodes | Suretek Medical | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 JOS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K983652 | Ablator ElectrodeSummary page 3…nd coagulates tissue. Kaa288s The UltrAblator™ Electrode is a modification of Linvatec’'s Ablator Electrode which received FDA clearance under 510(k)}# K983652 on March 23, 1999. The electrode will be made available in a range of sizes from 2.4”" to 6.3" inches in working length, and in t… | 1999 |
| * | K944992 | ElectrodesSummary page 5…er : Various Company Name : Linvatec Corporation 510(k) # . K983652 2. ESA Electrode (Exhibit 7) Catalog Number : Various Company Name : Linvatec Corporation 510(k)# . #944992 The similarities/dissimilarities to the predicates are shown in the table on the following page. \4,095665 (p‘… | 1995 |
What descends from it? (6)
3 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?
How does its category compare?
All JOS devicesJOS Electrode, Electrosurgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JOS
Too few JOS 510(k)s in any year since 2007 to give a median.
Recalls per year · JOS
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOS
6in 2025
MAUDE reports naming product code JOS, 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 | 0 | — | 0 | 29 |
| 2008 | 0 | — | 1 | 37 |
| 2009 | 0 | — | 0 | 62 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 2 | 7 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 10 |
| 2019 | 0 | — | 2 | 17 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The UltrAblator™ Electrode is intended to be used in arthroscopic applications of resection, ablation, tissue modification, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues. Arthroscopic surgery includes the following: Knee 1. Meniscectomy 2. Lateral Release 3. Chondroplasty 4. Synovectomy 5. ACL Debridement 6. Plica Removal 7. Meniscal Cystectomy Ankle 1. Fracture Debridement 2. Excision of scar tissue 3. Synovectomy…
Read the full statement (97 words)
The UltrAblator™ Electrode is intended to be used in arthroscopic applications of resection, ablation, tissue modification, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues. Arthroscopic surgery includes the following:
Knee
1. Meniscectomy
2. Lateral Release
3. Chondroplasty
4. Synovectomy
5. ACL Debridement
6. Plica Removal
7. 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
Labral Tear Resection
Synovectomy
Excision of Scar Tissue
Acromioplasty
Bursectomy
Subacromial Decompression
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/K993885 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993885: Ultrablator Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993885
Report an extraction error
Are you the manufacturer?
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