510(k) · Cleared
ClearedHarmonic Hook
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 Mar 4, 2016 as substantially equivalent to K990362 (Ethicon Endo-Surgery, Inc., 1999) and 1 other predicate after a 310-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.
- Decided
- Mar 4, 2016
- Review
- 310 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K881763 (1988). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK881763 Colorado Needle ElectrodeColorado Biomedical, Inc. · 1988
- 1 generation backK990362 Instrument, Ultrasonic, ScalpelEthicon Endo-Surgery, Inc. · 1999
- This deviceK151136 Harmonic HookEthicon Endo-Surgery, LLC · 2016
- Descendant · cites it directly · 0 of its ownK233036 Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K881763 | Colorado Needle Electrode | Colorado Biomedical, Inc. | 1988 | — |
| −1 | K990362 | Instrument, Ultrasonic, Scalpel | Ethicon Endo-Surgery, Inc. | 1999 | — |
| 0 (this device) | K151136 | Harmonic Hook | Ethicon Endo-Surgery, LLC | 2016 | — |
| +1 | K233036 | Ultrasonic Surgical System | Hunan Handlike Minimally Invasive Surgery Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K990362 | Instrument, Ultrasonic, ScalpelSummary page 4…ssification Name Instrument, Ultrasonic Surgical (Unassigned, Product Code LFL) Regulatory Class Unclassified Predicate Device HARMONIC 5mm instrument, cleared under K990362 on 17 September 1999 HARMONIC 5mm Instrument, last cleared under K060245 on 7 April 2006 The predicate device characteristics ar… | 1999 |
| * | K060245 | Harmonic Scalpel Blades and ShearsSummary page 4…de LFL) Regulatory Class Unclassified Predicate Device HARMONIC 5mm instrument, cleared under K990362 on 17 September 1999 HARMONIC 5mm Instrument, last cleared under K060245 on 7 April 2006 The predicate device characteristics are described in K990362 when it was first cleared. The predicate device ha… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233036 | Ultrasonic Surgical System | 2024 | 0 |
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 28 years and passes through 3 companies; a new generation was cleared every 16.5 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K233036 (Hunan Handlike Minimally Invasive Surgery Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K990362.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Hook instrument is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space), and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151136 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151136: Harmonic Hook.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151136
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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