510(k) · Cleared
ClearedGeenen/Zebra Guidelines
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · FDE Laparoscopy Kit
Cleared on Jul 21, 1994 after a 44-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jul 21, 1994
- Review
- 44 days
- Class
- Class II
- Product code
- FDE
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK942677 Geenen/Zebra GuidelinesBoston Scientific Corp · 1994
- Descendant · cites it directly · 4 of its ownK011759 Radius Next Generation GuidewireRadius Medical Technologies, Inc. · 2001
- Descendant · 2 generations on · 2 of its ownK023603 Endo-Glide GuidewireEndo-Therapeutics, Inc. · 2003
- Descendant · 3 generations on · 1 of its ownK051068 Zutron Colonoscope Stiffening DeviceZutron Medical · 2005
- Descendant · 4 generations on · 0 of its ownK251204 FUJIFILM Stiffening Wire Device (SW-2000)FUJIFILM Healthcare Americas Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK050304 FX Wire Advanced Measurement GuidewireConmedcorp · 2005
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K011759Radius Next Generation GuidewireRadius Medical Technologies, Inc. · 2001 · cites it directly4descendants
- K023603Endo-Glide GuidewireEndo-Therapeutics, Inc. · 2003 · 2 generations on2descendants
- K051068Zutron Colonoscope Stiffening DeviceZutron Medical · 2005 · 3 generations on1descendant
- K251204FUJIFILM Stiffening Wire Device (SW-2000)FUJIFILM Healthcare Americas Corporation · 2025 · 4 generations on0descendants
- K050304FX Wire Advanced Measurement GuidewireConmedcorp · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942677 | Geenen/Zebra Guidelines | Boston Scientific Corp | 1994 | — |
| +1 | K011759 | Radius Next Generation Guidewire | Radius Medical Technologies, Inc. | 2001 | — |
| +2 | K023603 | Endo-Glide Guidewire | Endo-Therapeutics, Inc. | 2003 | — |
| +3 | K051068 | Zutron Colonoscope Stiffening Device | Zutron Medical | 2005 | — |
| +4 | K251204 | FUJIFILM Stiffening Wire Device (SW-2000) | FUJIFILM Healthcare Americas Corporation | 2025 | — |
| +2 | K050304 | FX Wire Advanced Measurement Guidewire | Conmedcorp | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FDE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
2 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, K011759 (Radius Medical Technologies, Inc., 2001) has gone furthest, with 4 descendants of its own.
How does its category compare?
All FDE devicesFDE Laparoscopy Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FDE
FDA has decided no FDE device since 2007.
Median 510(k) review, days · FDE
Too few FDE 510(k)s in any year since 2007 to give a median.
Recalls per year · FDE
3in 2025
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FDE
17in 2025
MAUDE reports naming product code FDE, 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 | 0 | — | 0 | 5 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 18 (18) | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 1 | 14 |
| 2021 | 0 | — | 0 | 18 |
| 2022 | 0 | — | 5 | 17 |
| 2023 | 0 | — | 4 | 23 |
| 2024 | 0 | — | 7 | 56 |
| 2025 | 0 | — | 3 (1) | 17 |
| 2026 | 0 | — | 16 | — |
https://510kreport.com/device/K942677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942677: Geenen/Zebra Guidelines.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942677
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026