510(k) · Cleared
ClearedBiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 2, 2020 as substantially equivalent to K182451 (Covidien, LLC, 2018) after an 89-day review. Its family tree reaches back 11 generations to 1994.
- Decided
- Mar 2, 2020
- Review
- 89 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K932293 (1994). 26 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 7 generations between
- 3 generations backK160539 BiZact Open Sealer/DividerCovidien · 2016
- 2 generations backK171066 BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC · 2017
- 1 generation backK182451 BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC · 2018
- This deviceK193356 BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC · 2020
Show all 11 generations
- Root · 11 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 10 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 9 generations backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
- 8 generations backK102470 Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, · 2011
- 7 generations backK113572 Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2012
- 6 generations backK133338 Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H · 2013
- 5 generations backK141153 Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip…Covidien · 2014
- 4 generations backK152286 LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien · 2015
- 3 generations backK160539 BiZact Open Sealer/DividerCovidien · 2016
- 2 generations backK171066 BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC · 2017
- 1 generation backK182451 BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC · 2018
- This deviceK193356 BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −10 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −9 | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | 2 |
| −8 | K102470 | Lugasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, | 2011 | — |
| −7 | K113572 | Ligasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, A Division of Tyco H | 2012 | — |
| −6 | K133338 | Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX) | Covidien, Formerly Valleylab, A Division of Tyco H | 2013 | — |
| −5 | K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider… | Covidien | 2014 | — |
| −4 | K152286 | LigaSure Curved, Small Jaw, Open Sealer/Divider | Covidien | 2015 | — |
| −3 | K160539 | BiZact Open Sealer/Divider | Covidien | 2016 | — |
| −2 | K171066 | BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider | Covidien, LLC | 2017 | — |
| −1 | K182451 | BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider | Covidien, LLC | 2018 | — |
| 0 (this device) | K193356 | BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider | Covidien, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K182451 | BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerSummary page 4…ed Bipolar Tissue Sealer/Divider Catalog Number: BZ4212A Common Name: Bipolar Vessel Sealing Device 510(k) Number: K182451 (cleared November 6, 2018) Manufacturer: Covidien llc Device Description The BiZact™ Tonsillectomy Device Adv… | 2018 |
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 26 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 26 ancestors have a recall of any class.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The BiZact device is a bipolar instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles and lymphatics is desired. The tissue fusion of the device can be used on vessels (arteries and veins) and lymphatics up to an including 3 mm diameter. The BiZact device is indicated for use in open general surgical procedures. It's also indicated for adult, children and adolescent ENT procedures (3 years of age…
Read the full statement (123 words)
The BiZact device is a bipolar instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles and lymphatics is desired. The tissue fusion of the device can be used on vessels (arteries and veins) and lymphatics up to an including 3 mm diameter. The BiZact device is indicated for use in open general surgical procedures.
It's also indicated for adult, children and adolescent ENT procedures (3 years of age and above), including tonsillectomy, for the ligation and division of vessels, tissue bundles and lymphatics 2-3 mm away from unintended thermally sensitive structures.
The BiZact device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use for these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193356 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193356: BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193356
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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