510(k) · Cleared
ClearedVIKY
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endocontrol · GCJ Laparoscope, General & Plastic Surgery
Cleared on Dec 18, 2008 as substantially equivalent to K972699 (Computer Motion, Inc., 1997) and 1 other predicate after a 133-day review. Its family tree reaches back 4 generations to 1993. 1 later device descends from it.
- Decided
- Dec 18, 2008
- Review
- 133 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K931783 (1993). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 3 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 2 generations backK963126 Aesop System and AccessoriesComputer Motion, Inc. · 1997
- 1 generation backK972699 Aesop 3000 System and AccessoriesComputer Motion, Inc. · 1997
- This deviceK082233 VIKYEndocontrol · 2008
- Descendant · cites it directly · 0 of its ownK122820 Viky UPEndocontrol · 2013
Most influential descendants
Showing 1 of 1 · See all- K122820Viky UPEndocontrol · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −3 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −2 | K963126 | Aesop System and Accessories | Computer Motion, Inc. | 1997 | — |
| −1 | K972699 | Aesop 3000 System and Accessories | Computer Motion, Inc. | 1997 | — |
| 0 (this device) | K082233 | VIKY | Endocontrol | 2008 | — |
| +1 | K122820 | Viky UP | Endocontrol | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K972699 | Aesop 3000 System and AccessoriesSummary page 1…II Product Code: GCJ Predicate Device: The ViKY System is substantially equivalent to AESOP 3000 System and accessories that were cleared by FDA under K972699 on December 17, 1997, and to GMPISurgical Solutions Inc. LaparocisionT M Scope Controller System that was cleared by FDA under K0… | 1997 |
| * | K050027 | Laparocision Scope Controller SystemSummary page 1…ies that were cleared by FDA under K972699 on December 17, 1997, and to GMPISurgical Solutions Inc. LaparocisionT M Scope Controller System that was cleared by FDA under K050027 on January 27, 2005. Device Description: ViKY is a motorized endloscope holder for thoracic, abdominal, and pelvic minimally inv… | 2005 |
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 |
|---|---|---|---|
| K122820 | Viky UP | 2013 | 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 15 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K122820 (Endocontrol, 2013) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K972699.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 ViKY System is indicated for thoracic and laparoscopic minimally invasive procedures for the purpose of holding and controlling the movement of standard rigid endoscopes within surgical cavities during endoscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082233: VIKY.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082233
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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