510(k) · Cleared
ClearedArmand Endoscope Holder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS-Martin L.P. · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 16, 2005 as substantially equivalent to K992006 (Integra Neurocare, LLC, 1999) and 1 other predicate after a 126-day review. Its family tree reaches back 2 generations to 1995. 9 later devices descend from it.
- Decided
- May 16, 2005
- Review
- 126 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K945572 (1995). 4 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK945572 Codman (R) Ridig and Steerable Endoscope Holder, Model 83-1352Johnson & Johnson Professionals, Inc. · 1995
- 1 generation backK992006 Neuroview Instrument Holder, Model 300-33Integra Neurocare, LLC · 1999
- This deviceK050051 Armand Endoscope HolderKLS-Martin L.P. · 2005
- Descendant · cites it directly · 4 of its ownK070509 Fisso Holding SystemBaitella AG · 2007
- Descendant · 2 generations on · 2 of its ownK190576 WalterLorenz Surgical Assist Arm Scope HolderBiomet Microfixation · 2019
- Descendant · cites it directly · 2 of its ownK061292 Statarius, Model 001 003Kinetic Surgical, LLC · 2006
- Descendant · 2 generations on · 1 of its ownK093616 V. Mueller Camera Controller with Storage CartCarefusion 2200 · 2009
- Descendant · 3 generations on · 0 of its ownK240506 KARL STORZ HoldersKarl Storz Endoscopy America, Inc. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K070509Fisso Holding SystemBaitella AG · 2007 · cites it directly4descendants
- K190576WalterLorenz Surgical Assist Arm Scope HolderBiomet Microfixation · 2019 · 2 generations on2descendants
- K061292Statarius, Model 001 003Kinetic Surgical, LLC · 2006 · cites it directly2descendants
- K093616V. Mueller Camera Controller with Storage CartCarefusion 2200 · 2009 · 2 generations on1descendant
- K240506KARL STORZ HoldersKarl Storz Endoscopy America, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945572 | Codman (R) Ridig and Steerable Endoscope Holder, Model 83-1352 | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −1 | K992006 | Neuroview Instrument Holder, Model 300-33 | Integra Neurocare, LLC | 1999 | — |
| 0 (this device) | K050051 | Armand Endoscope Holder | KLS-Martin L.P. | 2005 | — |
| +1 | K070509 | Fisso Holding System | Baitella AG | 2007 | — |
| +2 | K190576 | WalterLorenz Surgical Assist Arm Scope Holder | Biomet Microfixation | 2019 | — |
| +1 | K061292 | Statarius, Model 001 003 | Kinetic Surgical, LLC | 2006 | — |
| +2 | K093616 | V. Mueller Camera Controller with Storage Cart | Carefusion 2200 | 2009 | — |
| +3 | K240506 | KARL STORZ Holders | Karl Storz Endoscopy America, Inc. | 2024 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2019 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K992006 | Neuroview Instrument Holder, Model 300-33Summary page 1…ies (CFR 876.1500) Regulatory Class: Class II Predicate Devices: Neuroview ® Instrument Holder (Model 300-33) (K992006) KSEA Endoscope Holder (K990334) Intended Use: The Armand Endoscope Holder is… | 1999 |
| * | K990334 | Ksea Endoscope HolderSummary page 1…icate Devices: Neuroview ® Instrument Holder (Model 300-33) (K992006) KSEA Endoscope Holder (K990334) Intended Use: The Armand Endoscope Holder is intended for use by surgeons for… | 1999 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K070509 (Baitella AG, 2007) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K992006.
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 Armand Endoscope Holder is intended for use by surgeons to hold rigid and
flexible endoscopes from 14.6mm to 15.8mm in diameter during diagnostic and
therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050051: Armand Endoscope Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050051
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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