510(k) · Cleared
ClearedSnowden-Pencer MicroLap 3mm Laparoscopic Instruments
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 May 4, 2017 as substantially equivalent to K102921 (Bema-GmbH & Co. KG, 2011) after a 133-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- May 4, 2017
- Review
- 133 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K935270 (1994). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK935270 Modular Forcep and Scissor SystemRichard Wolf Medical Instruments Corp. · 1994
- 2 generations backK033249 Pajunk Modular Handle InstrumentsPajunk GmbH · 2004
- 1 generation backK102921 Endoscopic Monopolar Instruments and AccessoriesBema-GmbH & Co. KG · 2011
- This deviceK163615 Snowden-Pencer MicroLap 3mm Laparoscopic InstrumentsCarefusion 2200, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK182013 EasyInstrumentsAgency For Medical Innovations GmbH · 2019
Most influential descendants
Showing 1 of 1 · See all- K182013EasyInstrumentsAgency For Medical Innovations GmbH · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935270 | Modular Forcep and Scissor System | Richard Wolf Medical Instruments Corp. | 1994 | — |
| −2 | K033249 | Pajunk Modular Handle Instruments | Pajunk GmbH | 2004 | — |
| −1 | K102921 | Endoscopic Monopolar Instruments and Accessories | Bema-GmbH & Co. KG | 2011 | — |
| 0 (this device) | K163615 | Snowden-Pencer MicroLap 3mm Laparoscopic Instruments | Carefusion 2200, Inc. | 2017 | — |
| +1 | K182013 | EasyInstruments | Agency For Medical Innovations GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K102921 | Endoscopic Monopolar Instruments and AccessoriesSummary page 4…Product Code(s) Multiple devices Legally marketed device(s) to BEMA Endoscopic Monopolar Instruments and Accessories – which equivalence is claimed K102921, GEI Reason for 510(k) submission Launch new 3mm product line Device description Snowden-Pencer MicroLap 3mm Lap… | 2011 |
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 |
|---|---|---|---|
| K182013 | EasyInstruments | 2019 | 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 23 years and passes through 4 companies; a new generation was cleared every 7.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K182013 (Agency For Medical Innovations GmbH, 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K102921.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 MicroLap 3mm Laparoscopic Instruments are indicated to be used in laparoscopic and other minimally invasive procedures for cutting, clamping, grasping, suturing and dissecting and to allow high frequency monopolar cutting and coagulation.
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/K163615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163615: Snowden-Pencer MicroLap 3mm Laparoscopic Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163615
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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