510(k) · Cleared
Recalled · 2012Harmonic Focus Curved Shears and Torque Wrench, Harmonic Blue Hand Piece and Test Tip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, LLC · LFL Instrument, Ultrasonic Surgical
Cleared on Jan 30, 2007 after a 102-day review. The FDA summary names its predicate without a number. 22 later devices descend from it. It has been recalled once.
- Decided
- Jan 30, 2007
- Review
- 102 days
- Class
- Class U
- Product code
- LFL
- Recalls
- 1
- Predicates
- 0
22 later devices descend from it, 5 citing it directly.
- This deviceK063192 Harmonic Focus Curved Shears and Torque Wrench, Harmonic Blue Hand…Ethicon Endo-Surgery, LLC · 2007
- Descendant · cites it directly · 18 of its ownK100597 Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010
- Descendant · 2 generations on · 9 of its ownK133314 Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC · 2013
- Descendant · 2 generations on · 6 of its ownK151743 THUNDERBEAT Open Fine JawOlympus Medical Systems Corp. · 2016
- Descendant · 3 generations on · 4 of its ownK192103 Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp. · 2020
- Descendant · 3 generations on · 4 of its ownK153371 Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC · 2016
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010 · cites it directly18descendants
- K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC · 2013 · 2 generations on9descendants
- K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp. · 2016 · 2 generations on6descendants
- K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp. · 2020 · 3 generations on4descendants
- K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC · 2016 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063192 | Harmonic Focus Curved Shears and Torque Wrench, Harmonic Blue Hand Piece and… | Ethicon Endo-Surgery, LLC | 2007 | — |
| +1 | K100597 | Harmonic Focus Shears | Ethicon Endo-Surgery, LLC | 2010 | — |
| +2 | K133314 | Harmonic Focus Shears + Adaptive Tissue Technology | Ethicon Endo-Surgery, LLC | 2013 | — |
| +2 | K151743 | THUNDERBEAT Open Fine Jaw | Olympus Medical Systems Corp. | 2016 | — |
| +3 | K192103 | Thunderbeat Open Fine Jaw Type X Hand Instrument | Olympus Medical Systems Corp. | 2020 | — |
| +3 | K153371 | Sonicision Cordless Ultrasonic Dissection Device | Covidien, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 LFL? 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 LFL device
- #1 K261448 neXus Ultrasonic Surgical Aspirator Systemscore 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | HARMONIC Scalpel Shears and Hand Piece Named without a submission number | |
| * | — | HARMONIC ACE™ Curved Shears with Scissor Handle and Hand Control Named without a submission number | |
| * | — | Ultracision Curved LCS/CS Shears Named without a submission number | |
| * | — | HARMONIC Scalpel Hand Piece Named without a submission number |
What descends from it? (22)
See all 225 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100597 | Harmonic Focus Shears | 2010 | 18 |
| K211273 | Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray | 2021 | 0 |
| K124033 | Medisiss Reprocessed Ultrasonic Instruments | 2014 | 0 |
| K111794 | Reprocessed Harmonic Scalpel | 2012 | 0 |
| K100537 | Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9… | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 16, 2012 | Not classified | Z-1673-2012 | Nonconforming Material/Component | Ethicon Endo-Surgery initiated a voluntary recall due to some lot numbers of the HARMONIC Hand Piece (HP054) and the HARMONIC Blue Hand Piece (HPBLUE), which impacts their compatibility with the HARMONIC Generator 300 (GEN04). The problem… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K100597 (Ethicon Endo-Surgery, LLC, 2010) has gone furthest, with 18 descendants of its own.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LFL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LFL
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFL
11in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFL
3,857in 2025
MAUDE reports naming product code LFL, 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 | 99 | 0 | 2,236 |
| 2008 | 2 | — | 0 | 1,678 |
| 2009 | 1 | — | 0 | 3,324 |
| 2010 | 2 | — | 3 | 1,239 |
| 2011 | 3 | 241 | 2 | 1,053 |
| 2012 | 3 | 82 | 5 | 1,491 |
| 2013 | 5 | 73 | 0 | 2,430 |
| 2014 | 3 | 136 | 1 | 4,260 |
| 2015 | 4 | 99 | 1 | 2,777 |
| 2016 | 5 | 111 | 0 | 2,691 |
| 2017 | 2 | — | 1 | 3,267 |
| 2018 | 3 | 66 | 0 | 3,461 |
| 2019 | 4 | 103 | 42 | 3,153 |
| 2020 | 4 | 190 | 0 | 2,934 |
| 2021 | 6 | 83 | 1 | 3,289 |
| 2022 | 8 | 168 | 0 | 3,422 |
| 2023 | 4 | 104 | 2 | 4,215 |
| 2024 | 3 | 158 | 11 | 4,017 |
| 2025 | 3 | 176 | 0 | 3,857 |
| 2026 | 3 | 99 | 1 | — |
What is it indicated for?
The HARMONIC FOCUS™ Shears are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.
The HARMONIC Blue Hand Piece, when used in conjunction with the HARMONIC Scalpel Instrument, is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels.
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/K063192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063192: Harmonic Focus Curved Shears and Torque Wrench, Harmonic Blue Hand Piece and Test Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063192
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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