510(k) · Cleared
ClearedSovereign Bipolar Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 30, 2000 as substantially equivalent to K954652 (Aesculap, Inc., 1996) and 2 other predicates after a 33-day review. Its family tree reaches back 4 generations to 1994. 6 later devices descend from it.
- Decided
- May 30, 2000
- Review
- 33 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K945975 (1994). 13 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK945975 Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp. · 1994
- 3 generations backK972558 Bipolar ScissorsEnable Medical Corp. · 1997
- 2 generations backK981219 Oscar Bipolar Scissors and Oscar Bipolar Reusable CartridgesEnable Medical Corp. · 1998
- 1 generation backK992996 Enable Endoscopic Bipolar ScissorsEnable Medical Corp. · 1999
- This deviceK001330 Sovereign Bipolar InstrumentsAesculap, Inc. · 2000
- Descendant · cites it directly · 3 of its ownK030890 SwitchbladeSnowden Pencer, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK113407 Snowden Pencer Laparoscopic Ergonomic Reposable ScissorsCarefusion 2200, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK160393 AdTecAesculap, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK132232 Mins Needlescopic Resposable Device SystemMinilap Technologies · 2013
- Descendant · 2 generations on · 0 of its ownK123260 Detachatip IiiConmed Corporation · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K030890SwitchbladeSnowden Pencer, Inc. · 2003 · cites it directly3descendants
- K113407Snowden Pencer Laparoscopic Ergonomic Reposable ScissorsCarefusion 2200, Inc. · 2012 · 2 generations on1descendant
- K160393AdTecAesculap, Inc. · 2016 · cites it directly0descendants
- K132232Mins Needlescopic Resposable Device SystemMinilap Technologies · 2013 · 3 generations on0descendants
- K123260Detachatip IiiConmed Corporation · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945975 | Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps | Everest Medical Corp. | 1994 | — |
| −3 | K972558 | Bipolar Scissors | Enable Medical Corp. | 1997 | — |
| −2 | K981219 | Oscar Bipolar Scissors and Oscar Bipolar Reusable Cartridges | Enable Medical Corp. | 1998 | — |
| −1 | K992996 | Enable Endoscopic Bipolar Scissors | Enable Medical Corp. | 1999 | — |
| 0 (this device) | K001330 | Sovereign Bipolar Instruments | Aesculap, Inc. | 2000 | — |
| +1 | K030890 | Switchblade | Snowden Pencer, Inc. | 2003 | — |
| +2 | K113407 | Snowden Pencer Laparoscopic Ergonomic Reposable Scissors | Carefusion 2200, Inc. | 2012 | — |
| +1 | K160393 | AdTec | Aesculap, Inc. | 2016 | — |
| +3 | K132232 | Mins Needlescopic Resposable Device System | Minilap Technologies | 2013 | — |
| +2 | K123260 | Detachatip Iii | Conmed Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K954652 | Aesculap Endosccopic Spine InstrumentsSummary page 1…equivalent in their intended use, material composition, labeling, design and basic operating principles to the following predicatedevices: " AesculapBipolarForceps(K954652) " Jarit Detacho BipolarSystem " Enable EndoscopicBipolarScissors(K992996) " ValleylabBiSureTmLaparoscopicBipol… | 1996 |
| * | K992996 | Enable Endoscopic Bipolar ScissorsSummary page 1…rating principles to the following predicatedevices: " AesculapBipolarForceps(K954652) " Jarit Detacho BipolarSystem " Enable EndoscopicBipolarScissors(K992996) " ValleylabBiSureTmLaparoscopicBipolarForceps(K983743)… | 1999 |
| * | K983743 | Bisure Laparoscopic Bipolar ForcepsSummary page 1…AesculapBipolarForceps(K954652) " Jarit Detacho BipolarSystem " Enable EndoscopicBipolarScissors(K992996) " ValleylabBiSureTmLaparoscopicBipolarForceps(K983743) 004 Public… | 1999 |
| * | — | Jarit Detacho Bipolar System Named without a submission number |
What descends from it? (6)
3 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?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K030890 (Snowden Pencer, Inc., 2003) has gone furthest, with 3 descendants of its own.
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 Sovereign Bipolar Instruments are intended to facilitate grasping, cutting and manipulation of soft tissue and blood vessels during laparoscopic procedures with the use of high-frequency electrical current (bipolar electrocautery).
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/K001330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001330: Sovereign Bipolar Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001330
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026