510(k) · Cleared
Recalled · Class II · 2021Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · LFL Instrument, Ultrasonic Surgical
Cleared on Mar 26, 2018 as substantially equivalent to K101797 (Covidien, Formerly Valleylab, A Division of Tyco, 2011) and 2 other predicates after a 66-day review. Its family tree reaches back 15 generations to 1994. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Mar 26, 2018
- Review
- 66 days
- Class
- Class U
- Product code
- LFL
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 15 generations to K936109 (1994). 119 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 11 generations between
- 3 generations backK100597 Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010
- 2 generations backK133314 Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC · 2013
- 1 generation backK153371 Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC · 2016
- This deviceK180149 Sonicision Reusable Generator, Sonicision Reusable Battery Pack…Covidien, LLC · 2018
- Descendant · cites it directly · 0 of its ownK212301 Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC · 2021
Show all 15 generations
- Root · 15 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 14 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 13 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 12 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 11 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 10 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 9 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 8 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 7 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 6 generations backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- 5 generations backK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- 4 generations backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- 3 generations backK100597 Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010
- 2 generations backK133314 Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC · 2013
- 1 generation backK153371 Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC · 2016
- This deviceK180149 Sonicision Reusable Generator, Sonicision Reusable Battery Pack…Covidien, LLC · 2018
Most influential descendants
Showing 1 of 1 · See all- K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −14 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −13 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −12 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −11 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −10 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −9 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −8 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −7 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −6 | K033257 | Arthrocare Ent Plasma Wands | Arthrocare Corp. | 2003 | — |
| −5 | K063538 | Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot… | Arthrocare Corp. | 2006 | — |
| −4 | K070374 | Arthrocare Ent Plasma Wand | Arthrocare Corp. | 2007 | 1 |
| −3 | K100597 | Harmonic Focus Shears | Ethicon Endo-Surgery, LLC | 2010 | — |
| −2 | K133314 | Harmonic Focus Shears + Adaptive Tissue Technology | Ethicon Endo-Surgery, LLC | 2013 | — |
| −1 | K153371 | Sonicision Cordless Ultrasonic Dissection Device | Covidien, LLC | 2016 | — |
| 0 (this device) | K180149 | Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision… | Covidien, LLC | 2018 | — |
| +1 | K212301 | Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device | Covidien, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 3 | 0 |
| 1990 | 1 | 0 |
| 1991 | 6 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 10 | 0 |
| 1995 | 11 | 0 |
| 1996 | 12 | 0 |
| 1997 | 5 | 0 |
| 1998 | 11 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (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 |
|---|---|---|---|
| * | K101797 | Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12, SCG, SCB…Summary page 4…y and the most recent 510(k) for each of these products. Component Description (Catalog Number) Applicable 510(k)s Sonicision Reusable Generator (SCG) K101797 K153371 Sonicision Reusable Battery (SCB) K101797… | 2011 |
| * | K153371 | Sonicision Cordless Ultrasonic Dissection DeviceSummary page 4…. Component Description (Catalog Number) Applicable 510(k)s Sonicision Reusable Generator (SCG) K101797 K153371 Sonicision Reusable Battery (SCB) K101797 K153371 39 cm Single use Di… | 2016 |
| * | K141371 | Sonicision Cordless Ultrasonic DissectorSummary page 4…K101797 K153371 39 cm Single use Dissector (SCD39x) K101797 13 cm Single use Dissector (SCD13) K141371 K153371 26 cm Single use Dissector (SCD26) K141371 48 cm Single use Di… | 2014 |
| † | K071708 | I45, I45S, I60, and I60S | 2007 |
| † | K073001 | Idrives, Idrivec, Idrivef | 2007 |
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 |
|---|---|---|---|
| K212301 | Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 12, 2021 | Class II | Z-0332-2022 | Under Investigation by firm | Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuit |
| Jun 23, 2021 | Class II | Z-2240-2021 | Under Investigation by firm | Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal burn, hemorrhage, or tissue damage and a delay of treatment while an… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 13 of the 119 ancestors have a recall of any class.
- Of its descendants, K212301 (Covidien, LLC, 2021) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K101797.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Sonicision™ Curved Jaw Cordless Ultrasonic Dissection Device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The Device 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 and endoscopic procedures. The Sonicision™ Cordless Ultrasonic Dissection Device can be used to coagulate isolated vessels up to and including 5 mm in diameter.
The Sonicision 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180149 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180149: Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180149
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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