510(k) · Cleared
ClearedStryker Scope/Instrument Holder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · GCJ Laparoscope, General & Plastic Surgery
Cleared on Apr 27, 2006 as substantially equivalent to K000663 (Kronner Prototypes, Inc., 2000) after a 106-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Apr 27, 2006
- Review
- 106 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K951854 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK951854 Leonard Arm - Support Arm - Endoscopic AccessoryLeonard Medical, Inc. · 1995
- 2 generations backK973543 Kronner Low Profile Scope HolderKronner Prototypes, Inc. · 1998
- 1 generation backK000663 Kronner Low Profile Scope HolderKronner Prototypes, Inc. · 2000
- This deviceK060085 Stryker Scope/Instrument HolderStryker Endoscopy · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951854 | Leonard Arm - Support Arm - Endoscopic Accessory | Leonard Medical, Inc. | 1995 | — |
| −2 | K973543 | Kronner Low Profile Scope Holder | Kronner Prototypes, Inc. | 1998 | — |
| −1 | K000663 | Kronner Low Profile Scope Holder | Kronner Prototypes, Inc. | 2000 | — |
| 0 (this device) | K060085 | Stryker Scope/Instrument Holder | Stryker Endoscopy | 2006 | — |
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 |
|---|---|---|---|
| * | K000663 | Kronner Low Profile Scope HolderSummary page 1…The Stryker Scope Holder is substantially equivalent in terms of safety and effectiveness to currently marketed devices, including the Kronner Low Profile Scope Holder (K000663). The Stryker Scope Holder is a new product developed by Stryker. The Stryker Scope Holder is an endoscopic accessory, composed o… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K000663.
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 Stryker Scope Holder is indicated for use in arthroscopic, nasal, abdominal and laparoscopic surgical procedures, 'including laparoscopic general surgery, thoracic surgery, and endoscopic surgery. The device is intended to hold endoscopes steady in a desired position during the previously mentioned procedures. In addition, the device allows for the rapid repositioning of these endoscopes, laparoscopes and accessories during these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060085 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060085: Stryker Scope/Instrument Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060085
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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