510(k) · Cleared
ClearedUltrasonic Scalpel System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · LFL Instrument, Ultrasonic Surgical
Cleared on Jul 18, 2022 as substantially equivalent to K141122 (Ethicon Endo-Surgery, LLC, 2014) and 1 other predicate after a 334-day review. Its family tree reaches back 9 generations to 1994. 1 later device descends from it.
- Decided
- Jul 18, 2022
- Review
- 334 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K932293 (1994). 62 ancestors in all, the oldest K852143 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 5 generations between
- 3 generations backK081129 Enseal…Surgrx, Inc. · 2008
- 2 generations backK101990 Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC · 2011
- 1 generation backK141122 Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC · 2014
- This deviceK212614 Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK233036 Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd. · 2024
Show all 9 generations
- Root · 9 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 8 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 7 generations backK031133 Surgrx Enseal Vessel Sealing and Hemostasis System Including the…Surgrx, Inc. · 2003
- 6 generations backK061526 Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2006
- 5 generations backK062949 Enseal PTC Tissue Seating Sealing DeviceSurgrx, Inc. · 2006
- 4 generations backK070165 Enseal PTC TrioSurgrx, Inc. · 2007 · Recalled
- 3 generations backK081129 Enseal…Surgrx, Inc. · 2008
- 2 generations backK101990 Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC · 2011
- 1 generation backK141122 Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC · 2014
- This deviceK212614 Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2022
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 |
|---|---|---|---|---|---|
| −9 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −8 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −7 | K031133 | Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal… | Surgrx, Inc. | 2003 | — |
| −6 | K061526 | Enseal PTC Tissue Sealing Device | Surgrx, Inc. | 2006 | — |
| −5 | K062949 | Enseal PTC Tissue Seating Sealing Device | Surgrx, Inc. | 2006 | — |
| −4 | K070165 | Enseal PTC Trio | Surgrx, Inc. | 2007 | 1 |
| −3 | K081129 | Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD… | Surgrx, Inc. | 2008 | — |
| −2 | K101990 | Ethicon Endo-Surgery Generator G11, Model GEN11 | Ethicon Endo-Sugery, LLC | 2011 | — |
| −1 | K141122 | Harmonic Scallop Blade, Generator G11 | Ethicon Endo-Surgery, LLC | 2014 | — |
| 0 (this device) | K212614 | Ultrasonic Scalpel System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2022 | — |
| +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 |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 9 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K141122 | Harmonic Scallop Blade, Generator G11Summary page 4…c Surgical Regulations Number: Unclassified Product Code: LFL Device Class: Unclassified Panel: General & Plastic Surgery 3.3 Predicate Device 510(k) K141122 K132612 Number 1/8 K212614… | 2014 |
| * | K132612 | Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace + Laparoscopic…Summary page 4…ed Product Code: LFL Device Class: Unclassified Panel: General & Plastic Surgery 3.3 Predicate Device 510(k) K141122 K132612 Number 1/8 K212614… | 2013 |
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 6 companies; a new generation was cleared every 3.0 years on median.
- 12 of the 62 ancestors have a recall of any class.
- Of its descendants, K233036 (Hunan Handlike Minimally Invasive Surgery Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K141122.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Ultrasonic Scalpel System is intended to be used to transect, dissect, and coagulate tissue. The instruments are indicated for use in open and endoscopic general surgical procedures where bleeding control and minimal thermal injury to tissue are desired. The instruments allow for the coagulation of vessels (veins and arteries) up to 5 mm in diameter while using the power level 1. Device have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures.
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/K212614 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212614: Ultrasonic Scalpel System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212614
Report an extraction error
Are you the manufacturer?
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