510(k) · Cleared
Cleared7MM Extended Length Endoscope,Dissection Tips, Models VH-1111, VH-1114
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 Jan 10, 2002 as substantially equivalent to K960637 (Origin Medsystems, Inc., 1996) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Jan 10, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K964171 (1997). 3 ancestors in all, the oldest K960637 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK964171 Vasoview Balloon Dissection SystemOrigin Medsystems, Inc. · 1997
- 1 generation backK981700 Vasoview Dissection/Vessel Harvesting SystemOrigin Medsystems, Inc. · 1998
- This deviceK014250 7MM Extended Length Endoscope,Dissection Tips, Models VH-1111, VH-1114Guidant Corp. · 2002
- Descendant · cites it directly · 0 of its ownK191930 7 mm Extended Length EndoscopeMaquet Cardiovascular, LLC · 2020
Most influential descendants
Showing 1 of 1 · See all- K1919307 mm Extended Length EndoscopeMaquet Cardiovascular, LLC · 2020 · cites it directly0descendants
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) | K014250 | 7MM Extended Length Endoscope,Dissection Tips, Models VH-1111, VH-1114 | Guidant Corp. | 2002 | — |
| +1 | K191930 | 7 mm Extended Length Endoscope | Maquet Cardiovascular, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K960637 | 5MM EndoscopeSummary page 2…al Equivalence The 7 mm Extended Length Endoscope with Dissection Tip is substantially equivalent to the 5mm Endoscope, cleared by the Food and Drug Administration under K960637 on June 14, 1996, and the VasoView™ Dissection Cannula, K981700, cleared on February 18, 1998. The design of the 7 mm Extended Le… | 1996 |
| * | K981700 | Vasoview Dissection/Vessel Harvesting SystemSummary page 2…n Tip is substantially equivalent to the 5mm Endoscope, cleared by the Food and Drug Administration under K960637 on June 14, 1996, and the VasoView™ Dissection Cannula, K981700, cleared on February 18, 1998. The design of the 7 mm Extended Length Endoscope with Dissection Tip is identical to the current E… | 1998 |
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 |
|---|---|---|---|
| K191930 | 7 mm Extended Length Endoscope | 2020 | 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 5 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K191930 (Maquet Cardiovascular, LLC, 2020) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K960637.
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 7 mm Extended Length Endoscope is indicated for visualization of a surgical cavity and dissection in endoscopic procedures and other minimally invasive surgical procedures allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic vessel harvesting for arterial bypass. It is indicated for patients requiring endoscopic tissue separation/vessel harvesting of the extraperitoneal or subcutaneous extremity and…
Read the full statement (99 words)
The 7 mm Extended Length Endoscope is indicated for visualization of a surgical cavity
and dissection in endoscopic procedures and other minimally invasive surgical
procedures allowing access for vessel harvesting, and is primarily indicated for patients
undergoing endoscopic vessel harvesting for arterial bypass. It is indicated for patients
requiring endoscopic tissue separation/vessel harvesting of the extraperitoneal or
subcutaneous extremity and thoracic space. Extremity procedures include tissue
dissection along the saphenous vein and the femoral vessels. Thoracoscopic 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014250 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014250: 7MM Extended Length Endoscope,Dissection Tips, Models VH-1111, VH-1114.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014250
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026