510(k) · Cleared
ClearedSonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12, SCG, SCB, SCSK, Sonicision Sterilization T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, Formerly Valleylab, A Division of Tyco · LFL Instrument, Ultrasonic Surgical
Cleared on Feb 24, 2011 as substantially equivalent to K002906 (Ethicon Endo-Surgery, Inc., 2000) and 3 other predicates after a 241-day review. Its family tree reaches back 7 generations to 1997. 5 later devices descend from it.
- Decided
- Feb 24, 2011
- Review
- 241 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K970720 (1997). 34 ancestors in all, the oldest K821994 (1982). 5 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK970720 Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO…Ethicon Endo-Surgery, Inc. · 1997
- 6 generations backK980815 Endopath EZ45 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 1998
- 5 generations backK020719 Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM…Power Medical Interventions, Inc. · 2002 · Recalled
- 4 generations backK030653 Surgassist Straight Linear Stapler and Straight Linear 4 Row NO…Power Medical Interventions, Inc. · 2003
- 3 generations backK040398 Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc. · 2004
- 2 generations backK040720 Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30…Power Medical Interventions, Inc. · 2004 · Recalled
- 1 generation backK071708 I45, I45S, I60, and I60SPower Medical Interventions, Inc. · 2007 · Recalled
- This deviceK101797 Sonicision Cordless Ultrasonic Dissection Device Model SCD391…Covidien, Formerly Valleylab, A Division of Tyco · 2011
- Descendant · cites it directly · 3 of its ownK141371 Sonicision Cordless Ultrasonic DissectorCovidien, Formerly Valleylab, A Division of Tyco H · 2014
- Descendant · cites it directly · 1 of its ownK180149 Sonicision Reusable Generator, Sonicision Reusable Battery Pack…Covidien, LLC · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK212301 Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC · 2021
- Descendant · cites it directly · 0 of its ownK170955 Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings Inc.(Dba Medline Ren · 2017
- Descendant · cites it directly · 0 of its ownK143562 Reprocessed Cordless Ultrasonic Dissection DeviceSterilmed, Inc. · 2015
Most influential descendants
Showing 5 of 5 · See all- K141371Sonicision Cordless Ultrasonic DissectorCovidien, Formerly Valleylab, A Division of Tyco H · 2014 · cites it directly3descendants
- K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC · 2018 · cites it directly1descendant
- K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC · 2021 · 2 generations on0descendants
- K170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings Inc.(Dba Medline Ren · 2017 · cites it directly0descendants
- K143562Reprocessed Cordless Ultrasonic Dissection DeviceSterilmed, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K970720 | Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO Knife… | Ethicon Endo-Surgery, Inc. | 1997 | — |
| −6 | K980815 | Endopath EZ45 Endoscopic Linear Cutter | Ethicon Endo-Surgery, Inc. | 1998 | — |
| −5 | K020719 | Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with… | Power Medical Interventions, Inc. | 2002 | 1 |
| −4 | K030653 | Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital… | Power Medical Interventions, Inc. | 2003 | — |
| −3 | K040398 | Surgassist Straight Linear 4 Row NO Knife Dlus with Reloads | Power Medical Interventions, Inc. | 2004 | — |
| −2 | K040720 | Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55… | Power Medical Interventions, Inc. | 2004 | 1 |
| −1 | K071708 | I45, I45S, I60, and I60S | Power Medical Interventions, Inc. | 2007 | 1 |
| 0 (this device) | K101797 | Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12… | Covidien, Formerly Valleylab, A Division of Tyco | 2011 | — |
| +1 | K141371 | Sonicision Cordless Ultrasonic Dissector | Covidien, Formerly Valleylab, A Division of Tyco H | 2014 | — |
| +1 | K180149 | Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision… | Covidien, LLC | 2018 | 2 |
| +2 | K212301 | Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device | Covidien, LLC | 2021 | — |
| +1 | K170955 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2017 | — |
| +1 | K143562 | Reprocessed Cordless Ultrasonic Dissection Device | Sterilmed, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K002906 | Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07Summary page 1…ltrasonic surgical devices: Device Name: Instrument, Ultrasonic, Scalpel Trade Name [Model Number]: Ultraision Harmonic Scalpel [GEN4; HP054] 510(k) Number: K002906 (cleared 12/15/2000) Manufacturer: Ethicon Endo-Surgery, Inc. Device Name: Harmonic ACE Curved Shears with Hand Control… | 2000 |
| * | K042777 | Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36PSummary page 1…ared 12/15/2000) Manufacturer: Ethicon Endo-Surgery, Inc. Device Name: Harmonic ACE Curved Shears with Hand Control Model Number: ACE36E 5 10(k) Number: K042777 (cleared 12/1/2004); K060245 (cleared 4/7/2006) Manufacturer: Ethicon Endo-Surgery, Inc. Aspects of the system related to th… | 2004 |
| * | K060245 | Harmonic Scalpel Blades and ShearsSummary page 1…urer: Ethicon Endo-Surgery, Inc. Device Name: Harmonic ACE Curved Shears with Hand Control Model Number: ACE36E 5 10(k) Number: K042777 (cleared 12/1/2004); K060245 (cleared 4/7/2006) Manufacturer: Ethicon Endo-Surgery, Inc. Aspects of the system related to the use of a rechargeable lithi… | 2006 |
| * | K071708 | I45, I45S, I60, and I60SSummary page 1…owing device: Device Name: Intelligent Surgical Instrument Trade Names: i45, i45S, i60, i60S [instruments]; iBlOO [battery]; iBICI [charger] 510O(k) Number: K07 1708 (cleared 9/27/2007) Manufacturer: Power Medical Interventions, Inc. K101797: SonicisionTm Cordless Ultrasonic Dissection… | 2007 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141371 | Sonicision Cordless Ultrasonic Dissector | 2014 | 3 |
| K180149 | Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw… | 2018 | 1 |
| K170955 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector | 2017 | 0 |
| K143562 | Reprocessed Cordless Ultrasonic Dissection Device | 2015 | 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 14 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 7 of the 34 ancestors have a recall of any class.
- Of its descendants, K141371 (Covidien, Formerly Valleylab, A Division of Tyco H, 2014) has gone furthest, with 3 descendants of its own.
- 9 other devices also cite its predicate K002906.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 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 5 mm in diameter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101797 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101797: Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12, SCG, SCB, SCSK, Sonicision Sterilization T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101797
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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