510(k) · Cleared
ClearedFlexview System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jul 31, 2006 as substantially equivalent to K030512 (Guidant Corp., 2003) and 1 other predicate after an 11-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it.
- Decided
- Jul 31, 2006
- Review
- 11 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K945975 (1994). 11 ancestors in all, the oldest K904993 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK945975 Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp. · 1994
- 3 generations backK020143 Vasoview 5 Harvesting CannulaGuidant Corporation, Cardiac Surgery · 2002 · Recalled
- 2 generations backK022718 Vasoview 6 Harvesting Cannula, Models VH-2000, VH-2001 & VH-2002Guidant Corporation, Cardiac Surgery · 2002
- 1 generation backK041981 Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant…Guidant Corporation · 2004 · Recalled
- This deviceK062050 Flexview SystemBoston Scientific · 2006
- Descendant · cites it directly · 0 of its ownK091350 Estech Hawkeye Introducer SystemsEndoscopic Technologies, Inc. D/B/A Estech · 2009
Most influential descendants
Showing 1 of 1 · See all- K091350Estech Hawkeye Introducer SystemsEndoscopic Technologies, Inc. D/B/A Estech · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945975 | Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps | Everest Medical Corp. | 1994 | — |
| −3 | K020143 | Vasoview 5 Harvesting Cannula | Guidant Corporation, Cardiac Surgery | 2002 | 1 |
| −2 | K022718 | Vasoview 6 Harvesting Cannula, Models VH-2000, VH-2001 & VH-2002 | Guidant Corporation, Cardiac Surgery | 2002 | — |
| −1 | K041981 | Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant Vasoview 6… | Guidant Corporation | 2004 | 2 |
| 0 (this device) | K062050 | Flexview System | Boston Scientific | 2006 | — |
| +1 | K091350 | Estech Hawkeye Introducer Systems | Endoscopic Technologies, Inc. D/B/A Estech | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 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 |
|---|---|---|---|
| * | K030512 | Guidant Vasoview Endoscopic Vessel Harvesting SystemSummary page 1…antial Guidant FLEXViewTm System are substantially equivalent to the predicate equivalence devices: VasoView®P Endoscopic Vessel Harvesting System (VV4), (K0305 12, cleared on May 10, 2003) and VasoView® 6 Harvesting Cannula (K041981, cleared on August… | 2003 |
| * | K041981 | Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant Vasoview 6 Accessory Pack…Summary page 1…valence devices: VasoView®P Endoscopic Vessel Harvesting System (VV4), (K0305 12, cleared on May 10, 2003) and VasoView® 6 Harvesting Cannula (K041981, cleared on August 20, 2004). Device The FLEXView~h System includes the following components: th… | 2004 |
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 |
|---|---|---|---|
| K091350 | Estech Hawkeye Introducer Systems | 2009 | 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 12 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K091350 (Endoscopic Technologies, Inc. D/B/A Estech, 2009) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K030512.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The Guidant FLEXViewTM System is indicated for use in minimally invasive surgery allowing access for delivery and placement of surgical instruments (e.g., Guidant Microwave Ablation Probe). It is indicated for patients requiring blunt dissection of tissue including structures in the thoracic space.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062050 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062050: Flexview System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062050
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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