510(k) · Cleared
Recalled · 2009Guidant Vasoview Endoscopic Vessel Harvesting System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corp. · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 14, 2003 as substantially equivalent to K904993 (Everest Medical Corp., 1991) and 4 other predicates after an 84-day review. Its family tree reaches back 2 generations to 1997. 5 of the 69 devices in its family, counting itself, have a Class I recall. 62 later devices descend from it. It has been recalled once.
- Decided
- May 14, 2003
- Review
- 84 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 2 generations to K964171 (1997). 6 ancestors in all, the oldest K904993 (1991). 62 later devices descend from it, 4 citing it directly. 5 of the 69 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK964171 Vasoview Balloon Dissection SystemOrigin Medsystems, Inc. · 1997
- 1 generation backK981700 Vasoview Dissection/Vessel Harvesting SystemOrigin Medsystems, Inc. · 1998
- This deviceK030512 Guidant Vasoview Endoscopic Vessel Harvesting SystemGuidant Corp. · 2003
- Descendant · cites it directly · 45 of its ownK060723 40 L High Flow Insufflator F113W.O.M. World of Medicine AG · 2006
- Descendant · 2 generations on · 44 of its ownK063367 45L Core Insufflator, Model F114W.O.M. World of Medicine AG · 2007 · Recalled
- Descendant · 3 generations on · 35 of its ownK103692 Sugiquest Airsealoptical Trocar & Cannula System with Integrated…Surgiquest, Inc. · 2011
- Descendant · 3 generations on · 32 of its ownK110294 High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · Recalled (Class I)
- Descendant · 4 generations on · 31 of its ownK122180 High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · Recalled (Class I)
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 62 · See all- K06072340 L High Flow Insufflator F113W.O.M. World of Medicine AG · 2006 · cites it directly45descendants
- K06336745L Core Insufflator, Model F114W.O.M. World of Medicine AG · 2007 · 2 generations on44descendants
- K103692Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc. · 2011 · 3 generations on35descendants
- K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · 3 generations on32descendants
- K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · 4 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964171 | Vasoview Balloon Dissection System | Origin Medsystems, Inc. | 1997 | — |
| −1 | K981700 | Vasoview Dissection/Vessel Harvesting System | Origin Medsystems, Inc. | 1998 | — |
| 0 (this device) | K030512 | Guidant Vasoview Endoscopic Vessel Harvesting System | Guidant Corp. | 2003 | — |
| +1 | K060723 | 40 L High Flow Insufflator F113 | W.O.M. World of Medicine AG | 2006 | — |
| +2 | K063367 | 45L Core Insufflator, Model F114 | W.O.M. World of Medicine AG | 2007 | 4 |
| +3 | K103692 | Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator… | Surgiquest, Inc. | 2011 | — |
| +3 | K110294 | High Flow Insufflation Unit Uhi-4 | Olympus Medical Systems Corporation | 2011 | Class I |
| +4 | K122180 | High Flow Insufflantion Unit | Olympus Medical Systems Corporation | 2012 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 1 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 1 |
| 2011 | 2 | 1 |
| 2012 | 4 | 1 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 1 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 9 | 0 |
| 2026 | 7 | 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.
5 devices in this family have a Class I recall. 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? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K904993 | Laparoscopic Electrosurgical DeviceSummary page 3…g materials, and manufacturing processes. The technological characteristics, packaging materials and manufacturing processes are unchanged from 5 10K numbers K904993, K945975, K960637, K974608, K98 1700 and K992353, their amendments and supplements. All devices are cleared through F… | 1991 |
| * | K945975 | Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsSummary page 3…ls, and manufacturing processes. The technological characteristics, packaging materials and manufacturing processes are unchanged from 5 10K numbers K904993, K945975, K960637, K974608, K98 1700 and K992353, their amendments and supplements. All devices are cleared through FDA or exe… | 1994 |
| * | K960637 | 5MM EndoscopeSummary page 3…anufacturing processes. The technological characteristics, packaging materials and manufacturing processes are unchanged from 5 10K numbers K904993, K945975, K960637, K974608, K98 1700 and K992353, their amendments and supplements. All devices are cleared through FDA or exempt. The presen… | 1996 |
| Kept off the family tree | K974608 | Unnamed device Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 3…ing processes. The technological characteristics, packaging materials and manufacturing processes are unchanged from 5 10K numbers K904993, K945975, K960637, K974608, K98 1700 and K992353, their amendments and supplements. All devices are cleared through FDA or exempt. The present submiss… | |
| * | K981700 | Vasoview Dissection/Vessel Harvesting SystemSummary page 3…sses. The technological characteristics, packaging materials and manufacturing processes are unchanged from 5 10K numbers K904993, K945975, K960637, K974608, K98 1700 and K992353, their amendments and supplements. All devices are cleared through FDA or exempt. The present submission is lim… | 1998 |
| * | K992353 | Blunt Tip Trocar PortSummary page 3…hnological characteristics, packaging materials and manufacturing processes are unchanged from 5 10K numbers K904993, K945975, K960637, K974608, K98 1700 and K992353, their amendments and supplements. All devices are cleared through FDA or exempt. The present submission is limited to an… | 1999 |
What descends from it? (62)
See all 624 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 5, 2009 | Not classified | Z-0614-2011 | Packaging | Sterility may be compromised by a loss of package integrity. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K052274Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000Guidant Corporation · 2005 · Cites it directly · ◆ in the 2005 descendants bar of FIG. 11 Class I recall
- K101274Vasoview Hemopro 2 Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K153194VASOVIEW HemoPro Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K060723 (W.O.M. World of Medicine AG, 2006) has gone furthest, with 45 descendants of its own.
- 11 other devices also cite its predicate K904993.
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 VasoView® Endoscopic Vessel harvesting system is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for patients requiring blunt dissection of tissue including dissection of blood vessels, separation of the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include…
Read the full statement (100 words)
The Guidant VasoView® Endoscopic Vessel harvesting system is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for patients requiring blunt dissection of tissue including dissection of blood vessels, separation of the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection along the saphenous vein or radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels, and other tissues of the chest wall.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030512: Guidant Vasoview Endoscopic Vessel Harvesting System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030512
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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