510(k) · Cleared
ClearedSonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
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 Nov 15, 2021 as substantially equivalent to K180149 (Covidien, LLC, 2018) and 1 other predicate after a 115-day review. Its family tree reaches back 16 generations to 1994.
- Decided
- Nov 15, 2021
- Review
- 115 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K936109 (1994). 125 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 16 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 12 generations between
- 3 generations backK133314 Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC · 2013
- 2 generations backK153371 Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC · 2016
- 1 generation backK180149 Sonicision Reusable Generator, Sonicision Reusable Battery Pack…Covidien, LLC · 2018 · Recalled
- This deviceK212301 Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC · 2021
Show all 16 generations
- Root · 16 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 15 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 14 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 13 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 12 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 11 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 10 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 9 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 8 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 7 generations backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- 6 generations backK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- 5 generations backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- 4 generations backK100597 Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010
- 3 generations backK133314 Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC · 2013
- 2 generations backK153371 Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC · 2016
- 1 generation backK180149 Sonicision Reusable Generator, Sonicision Reusable Battery Pack…Covidien, LLC · 2018 · Recalled
- This deviceK212301 Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −15 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −14 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −13 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −12 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −11 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −10 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −9 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −8 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −7 | K033257 | Arthrocare Ent Plasma Wands | Arthrocare Corp. | 2003 | — |
| −6 | K063538 | Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot… | Arthrocare Corp. | 2006 | — |
| −5 | K070374 | Arthrocare Ent Plasma Wand | Arthrocare Corp. | 2007 | 1 |
| −4 | K100597 | Harmonic Focus Shears | Ethicon Endo-Surgery, LLC | 2010 | — |
| −3 | K133314 | Harmonic Focus Shears + Adaptive Tissue Technology | Ethicon Endo-Surgery, LLC | 2013 | — |
| −2 | K153371 | Sonicision Cordless Ultrasonic Dissection Device | Covidien, LLC | 2016 | — |
| −1 | K180149 | Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision… | Covidien, LLC | 2018 | 2 |
| 0 (this device) | 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 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K180149 | Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Summary page 4…GAA, SCBA Common Name: Ultrasonic Dissection Device Classification Name: None Established (unclassified, product code LFL) 510(k) Number: K180149 (cleared March 26, 2018) Manufacturer: Covidien llc Recalls: This predicate was the subject to a r… | 2018 |
| * | K132612 | Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace + Laparoscopic…Summary page 4…6, HARH45 Common Name: Ultrasonic Dissection Device Classification Name: None Established (unclassified, product code LFL) 510(k) Number: K132612 (cleared October 17, 2013) Manufacturer: Ethicon Recalls: This predicate has not been subject to a… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 17 of the 125 ancestors have a recall of any class.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 SonicisionTM 7 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, gynecologic, urologic, and other open and endoscopic procedures. The device can be used to coagulate isolated vessels up to and including 7 mm in diameter, using the…
Read the full statement (143 words)
The SonicisionTM 7 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, gynecologic, urologic, and other open and endoscopic procedures. The device
can be used to coagulate isolated vessels up to and including 7 mm in diameter, using the minimum mode. The device can
be used to coagulate isolated vessels up to and including 5 mm in diameter, using the maximum mode.
The SonicisionTm 7 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.
The SonicisionTm reusable battery pack is a non-sterile, rechargeable, lithium-ion battery that provides power to
compatible surgical devices. For full device indications for use, reference the indications for use statements of the
compatible devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212301 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212301: Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212301
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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