510(k) · Cleared
ClearedEthicon Bipolar Scissors and Accessory Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 5, 1996 after a 64-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 14 later devices descend from it.
- Decided
- Apr 5, 1996
- Review
- 64 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
14 later devices descend from it, 2 citing it directly.
- This deviceK960476 Ethicon Bipolar Scissors and Accessory CableETHICON, Inc. · 1996
- Descendant · cites it directly · 13 of its ownK972558 Bipolar ScissorsEnable Medical Corp. · 1997
- Descendant · cites it directly · 8 of its ownK981219 Oscar Bipolar Scissors and Oscar Bipolar Reusable CartridgesEnable Medical Corp. · 1998
- Descendant · 2 generations on · 7 of its ownK992996 Enable Endoscopic Bipolar ScissorsEnable Medical Corp. · 1999
- Descendant · 3 generations on · 6 of its ownK001330 Sovereign Bipolar InstrumentsAesculap, Inc. · 2000
- Descendant · 2 generations on · 4 of its ownK042077 Bitech Bipolar ScissorsGuenter Bissinger Medizintechnik GmbH · 2004
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K972558Bipolar ScissorsEnable Medical Corp. · 1997 · cites it directly13descendants
- K981219Oscar Bipolar Scissors and Oscar Bipolar Reusable CartridgesEnable Medical Corp. · 1998 · cites it directly8descendants
- K992996Enable Endoscopic Bipolar ScissorsEnable Medical Corp. · 1999 · 2 generations on7descendants
- K001330Sovereign Bipolar InstrumentsAesculap, Inc. · 2000 · 3 generations on6descendants
- K042077Bitech Bipolar ScissorsGuenter Bissinger Medizintechnik GmbH · 2004 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960476 | Ethicon Bipolar Scissors and Accessory Cable | ETHICON, Inc. | 1996 | — |
| +1 | K972558 | Bipolar Scissors | Enable Medical Corp. | 1997 | — |
| +1 | K981219 | Oscar Bipolar Scissors and Oscar Bipolar Reusable Cartridges | Enable Medical Corp. | 1998 | — |
| +2 | K992996 | Enable Endoscopic Bipolar Scissors | Enable Medical Corp. | 1999 | — |
| +3 | K001330 | Sovereign Bipolar Instruments | Aesculap, Inc. | 2000 | — |
| +2 | K042077 | Bitech Bipolar Scissors | Guenter Bissinger Medizintechnik GmbH | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2026 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K960470 | FDA’s K960470 is Neuro-Patch Our OCR of the scanned summary read K960470, which FDA decided on May 10, 1996, after this device was decided (Apr 5, 1996), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 1K960470b SECTION ~ SUMMARY OF SAFETY AND EFFECTIVENESS 510(k) Summary of Safety and Effectiveness Device Description Information sup… | 1996 |
What descends from it? (14)
See all 142 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?
- Of its descendants, K972558 (Enable Medical Corp., 1997) has gone furthest, with 13 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 ETHICON Bipolar Scissors are non-sterile, reusable devices intended to facilitate cutting and bipolar coagulation of soft tissue in open surgical 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/K960476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960476: Ethicon Bipolar Scissors and Accessory Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960476
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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