510(k) · Cleared
ClearedPowerstar Bipolar Scissors
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 Oct 29, 1997 after a 65-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Oct 29, 1997
- Review
- 65 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK973173 Powerstar Bipolar ScissorsETHICON, Inc. · 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 · 4 generations on · 3 of its ownK030890 SwitchbladeSnowden Pencer, Inc. · 2003
- Descendant · 5 generations on · 1 of its ownK113407 Snowden Pencer Laparoscopic Ergonomic Reposable ScissorsCarefusion 2200, Inc. · 2012
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- 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
- K030890SwitchbladeSnowden Pencer, Inc. · 2003 · 4 generations on3descendants
- K113407Snowden Pencer Laparoscopic Ergonomic Reposable ScissorsCarefusion 2200, Inc. · 2012 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973173 | Powerstar Bipolar Scissors | ETHICON, Inc. | 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 | — |
| +4 | K030890 | Switchblade | Snowden Pencer, Inc. | 2003 | — |
| +5 | K113407 | Snowden Pencer Laparoscopic Ergonomic Reposable Scissors | Carefusion 2200, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | — | PowerStar Bipolar Scissors Named without a submission number |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981219 | Oscar Bipolar Scissors and Oscar Bipolar Reusable Cartridges | 1998 | 8 |
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, K981219 (Enable Medical Corp., 1998) has gone furthest, with 8 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 PowerStar Bipolar Scissors are non-sterile, reusable devices intended to facilitate cutting and bipolar coagulation of soft tissue in open surgical procedures such as general, gynecological, oncologic, vascular, plastic, thoracic, ear, nose and throat, urological, and cardiovascular surgeries.
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/K973173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973173: Powerstar Bipolar Scissors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973173
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