510(k) · Cleared
ClearedStatarius, Model 001 003
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kinetic Surgical, LLC · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jul 3, 2006 as substantially equivalent to K050051 (KLS-Martin L.P., 2005) after a 55-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.
- Decided
- Jul 3, 2006
- Review
- 55 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945572 (1995). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK945572 Codman (R) Ridig and Steerable Endoscope Holder, Model 83-1352Johnson & Johnson Professionals, Inc. · 1995
- 2 generations backK992006 Neuroview Instrument Holder, Model 300-33Integra Neurocare, LLC · 1999
- 1 generation backK050051 Armand Endoscope HolderKLS-Martin L.P. · 2005
- This deviceK061292 Statarius, Model 001 003Kinetic Surgical, LLC · 2006
- Descendant · cites it directly · 1 of its ownK093616 V. Mueller Camera Controller with Storage CartCarefusion 2200 · 2009
- Descendant · 2 generations on · 0 of its ownK102179 Enview (TM)Carefusion 2200 · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945572 | Codman (R) Ridig and Steerable Endoscope Holder, Model 83-1352 | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −2 | K992006 | Neuroview Instrument Holder, Model 300-33 | Integra Neurocare, LLC | 1999 | — |
| −1 | K050051 | Armand Endoscope Holder | KLS-Martin L.P. | 2005 | — |
| 0 (this device) | K061292 | Statarius, Model 001 003 | Kinetic Surgical, LLC | 2006 | — |
| +1 | K093616 | V. Mueller Camera Controller with Storage Cart | Carefusion 2200 | 2009 | — |
| +2 | K102179 | Enview (TM) | Carefusion 2200 | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 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? (1)
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 |
|---|---|---|---|
| * | K050051 | Armand Endoscope HolderSummary page 1…Common Name: Endoscope Holder Regulatory Class: Class II Predicate Device: Armand Endoscope Holder (K5050051) Intended Use: The StatariusTM is intended for use by surgeons for holding rigid and… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093616 | V. Mueller Camera Controller with Storage Cart | 2009 | 1 |
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 11 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K093616 (Carefusion 2200, 2009) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K050051.
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 Statarius T M is intended for use by surgeons for holding rigid and flexible endoscopes with diameters from 5-12mm during diagnostic and therapeutic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061292 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061292: Statarius, Model 001 003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061292
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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