510(k) · Cleared
ClearedStorz S2050 Series Bipolar Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Storz Instrument Co. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 6, 1996 after a 64-day review. The FDA summary names its predicate without a number. 211 later devices descend from it.
- Decided
- Mar 6, 1996
- Review
- 64 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
211 later devices descend from it, 3 citing it directly.
- This deviceK960009 Storz S2050 Series Bipolar ForcepsStorz Instrument Co. · 1996
- Descendant · cites it directly · 202 of its ownK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- Descendant · 2 generations on · 128 of its ownK051644 Valleylab Forcetriad Electrosurgical GeneratorValleylab · 2005
- Descendant · 2 generations on · 114 of its ownK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 102 of its ownK070162 Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP · 2007
- Descendant · 3 generations on · 65 of its ownK092879 Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab · 2009 · Recalled
Showing 5 of 211 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 211 · See all- K981916Ligasure Vessel Sealing SystemValleylab, Inc. · 1998 · cites it directly202descendants
- K051644Valleylab Forcetriad Electrosurgical GeneratorValleylab · 2005 · 2 generations on128descendants
- K031011Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · 2 generations on114descendants
- K070162Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP · 2007 · 3 generations on102descendants
- K092879Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab · 2009 · 3 generations on65descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960009 | Storz S2050 Series Bipolar Forceps | Storz Instrument Co. | 1996 | — |
| +1 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| +2 | K051644 | Valleylab Forcetriad Electrosurgical Generator | Valleylab | 2005 | — |
| +2 | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | 2 |
| +3 | K070162 | Forcetriad Electrosurgical Generator; Ligasure Instruments | Valleylab,A Division of Tyco Healthcare Group LP | 2007 | — |
| +3 | K092879 | Ligasure 5MM Blunt Tip Laparoscopic Sealer-Divider | Valleylab | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 10 | 0 |
| 2012 | 6 | 0 |
| 2013 | 9 | 0 |
| 2014 | 11 | 0 |
| 2015 | 14 | 0 |
| 2016 | 16 | 0 |
| 2017 | 13 | 0 |
| 2018 | 18 | 0 |
| 2019 | 7 | 0 |
| 2020 | 10 | 0 |
| 2021 | 12 | 0 |
| 2022 | 11 | 0 |
| 2023 | 12 | 0 |
| 2024 | 11 | 0 |
| 2025 | 7 | 0 |
| 2026 | 10 | 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? (2)
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 |
|---|---|---|---|
| * | — | Kirwan Bipolar Forceps Named without a submission number | |
| * | — | Mentor O&O WET-FIELD Bipolar Forceps Named without a submission number |
What descends from it? (211)
See all 2113 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, K981916 (Valleylab, Inc., 1998) has gone furthest, with 202 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 Storz S2050 series of bipolar forceps are used to control bleeding during surgical procedures, using high frequency electric current. Several of the forceps are designed for ophthalmic procedures specifically, while others are marketed for ENT procedures, neurosurgery, and/or plastic and reconstructive surgery. The forceps function by pinching tissue between the forcep tips, and allowing electric current to pass through it. The affected tissue is coagulated, and bleeding is arrested.
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/K960009 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960009: Storz S2050 Series Bipolar Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960009
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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