510(k) · Cleared
ClearedBisure Laparoscopic Bipolar Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valleylab, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 21, 1999 as substantially equivalent to K955623 (Olympus America, Inc., 1996) after a 90-day review. Its family tree reaches back 1 generation to 1996. 8 later devices descend from it.
- Decided
- Jan 21, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955623 (1996). 8 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK955623 Olympus Bipolar ForcepsOlympus America, Inc. · 1996
- This deviceK983743 Bisure Laparoscopic Bipolar ForcepsValleylab, Inc. · 1999
- Descendant · cites it directly · 6 of its ownK001330 Sovereign Bipolar InstrumentsAesculap, Inc. · 2000
- Descendant · 2 generations on · 3 of its ownK030890 SwitchbladeSnowden Pencer, Inc. · 2003
- Descendant · 3 generations on · 1 of its ownK113407 Snowden Pencer Laparoscopic Ergonomic Reposable ScissorsCarefusion 2200, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK160393 AdTecAesculap, Inc. · 2016
- Descendant · 4 generations on · 0 of its ownK132232 Mins Needlescopic Resposable Device SystemMinilap Technologies · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K001330Sovereign Bipolar InstrumentsAesculap, Inc. · 2000 · cites it directly6descendants
- K030890SwitchbladeSnowden Pencer, Inc. · 2003 · 2 generations on3descendants
- K113407Snowden Pencer Laparoscopic Ergonomic Reposable ScissorsCarefusion 2200, Inc. · 2012 · 3 generations on1descendant
- K160393AdTecAesculap, Inc. · 2016 · 2 generations on0descendants
- K132232Mins Needlescopic Resposable Device SystemMinilap Technologies · 2013 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955623 | Olympus Bipolar Forceps | Olympus America, Inc. | 1996 | — |
| 0 (this device) | K983743 | Bisure Laparoscopic Bipolar Forceps | Valleylab, Inc. | 1999 | — |
| +1 | K001330 | Sovereign Bipolar Instruments | Aesculap, Inc. | 2000 | — |
| +2 | K030890 | Switchblade | Snowden Pencer, Inc. | 2003 | — |
| +3 | K113407 | Snowden Pencer Laparoscopic Ergonomic Reposable Scissors | Carefusion 2200, Inc. | 2012 | — |
| +2 | K160393 | AdTec | Aesculap, Inc. | 2016 | — |
| +4 | K132232 | Mins Needlescopic Resposable Device System | Minilap Technologies | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 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 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 |
|---|---|---|---|
| * | K955623 | Olympus Bipolar ForcepsSummary page 1…eps Common Name: Laparoscopic Bipolar Forceps Classification Name: Electrosurgical Cutting & Coagulation and Accessories IV. Predicate Device Olympus Bipolar Forceps (K955623) Device Description The BiSure™ Laparoscopic Bipolar Forceps is a coagulating forceps device that is intended for laparoscopic… | 1996 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 BiSure™ Laparoscopic Bipolar Forceps is indicated for use during laparoscopic bipolar coagulation.
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/K983743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983743: Bisure Laparoscopic Bipolar Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983743
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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