510(k) · Cleared
ClearedSnowden Pencer Laparoscopic Ergonomic Reposable Scissors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carefusion 2200, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 7, 2012 as substantially equivalent to K030890 (Snowden Pencer, Inc., 2003) and 1 other predicate after a 294-day review. Its family tree reaches back 6 generations to 1994. 1 later device descends from it.
- Decided
- Sep 7, 2012
- Review
- 294 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K945975 (1994). 18 ancestors in all, the oldest K931340 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK945975 Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp. · 1994
- 5 generations backK972558 Bipolar ScissorsEnable Medical Corp. · 1997
- 4 generations backK981219 Oscar Bipolar Scissors and Oscar Bipolar Reusable CartridgesEnable Medical Corp. · 1998
- 3 generations backK992996 Enable Endoscopic Bipolar ScissorsEnable Medical Corp. · 1999
- 2 generations backK001330 Sovereign Bipolar InstrumentsAesculap, Inc. · 2000
- 1 generation backK030890 SwitchbladeSnowden Pencer, Inc. · 2003
- This deviceK113407 Snowden Pencer Laparoscopic Ergonomic Reposable ScissorsCarefusion 2200, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK132232 Mins Needlescopic Resposable Device SystemMinilap Technologies · 2013
Most influential descendants
Showing 1 of 1 · See all- K132232Mins Needlescopic Resposable Device SystemMinilap Technologies · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945975 | Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps | Everest Medical Corp. | 1994 | — |
| −5 | K972558 | Bipolar Scissors | Enable Medical Corp. | 1997 | — |
| −4 | K981219 | Oscar Bipolar Scissors and Oscar Bipolar Reusable Cartridges | Enable Medical Corp. | 1998 | — |
| −3 | K992996 | Enable Endoscopic Bipolar Scissors | Enable Medical Corp. | 1999 | — |
| −2 | K001330 | Sovereign Bipolar Instruments | Aesculap, Inc. | 2000 | — |
| −1 | K030890 | Switchblade | Snowden Pencer, Inc. | 2003 | — |
| 0 (this device) | K113407 | Snowden Pencer Laparoscopic Ergonomic Reposable Scissors | Carefusion 2200, Inc. | 2012 | — |
| +1 | K132232 | Mins Needlescopic Resposable Device System | Minilap Technologies | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (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 |
|---|---|---|---|
| * | K030890 | SwitchbladeSummary page 1…egulation 878.4800 Product Code GEl, HET Legally marketed device(s) to which K030890 - Snowden-Pencer Switchbladle equivalence is claimed Scissors… | 2003 |
| * | K931340 | Grasp Forceps/Scissors/Needle Holder/DissectorSummary page 1…which K030890 - Snowden-Pencer Switchbladle equivalence is claimed Scissors K931340 - V. Mueller Laparoscopic Scissors Reason for 510(k) submission Modify the take-apart feature on the device… | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132232 | Mins Needlescopic Resposable Device System | 2013 | 0 |
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 18 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K132232 (Minilap Technologies, 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K030890.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 Snowden-Pencer Laparoscopic Ergonomic Reposable Scissors is a monopolar electrosutgical instrument indicated to be used in general laparoscopic and gynecologic procedures to allow high frequency monopolar cutting and coagulation. The reposable scissors are indicated to mechanically cut tissue and suture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113407 · printed Nov 3, 2026
Cite this page
510(k) Report. “K113407: Snowden Pencer Laparoscopic Ergonomic Reposable Scissors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113407
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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