510(k) · Cleared
ClearedKronner Low Profile Scope Holder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kronner Prototypes, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 2, 2000 as substantially equivalent to K973543 (Kronner Prototypes, Inc., 1998) after a 64-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- May 2, 2000
- Review
- 64 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K951854 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK951854 Leonard Arm - Support Arm - Endoscopic AccessoryLeonard Medical, Inc. · 1995
- 1 generation backK973543 Kronner Low Profile Scope HolderKronner Prototypes, Inc. · 1998
- This deviceK000663 Kronner Low Profile Scope HolderKronner Prototypes, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK090792 Mitaka UniarmMitaka Kohki Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK060085 Stryker Scope/Instrument HolderStryker Endoscopy · 2006
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 |
|---|---|---|---|---|---|
| −2 | K951854 | Leonard Arm - Support Arm - Endoscopic Accessory | Leonard Medical, Inc. | 1995 | — |
| −1 | K973543 | Kronner Low Profile Scope Holder | Kronner Prototypes, Inc. | 1998 | — |
| 0 (this device) | K000663 | Kronner Low Profile Scope Holder | Kronner Prototypes, Inc. | 2000 | — |
| +1 | K090792 | Mitaka Uniarm | Mitaka Kohki Co., Ltd. | 2009 | — |
| +1 | K060085 | Stryker Scope/Instrument Holder | Stryker Endoscopy | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K973543 | Kronner Low Profile Scope HolderSummary page 7…Endoscope Holder Classification Name: Endoscope holding device (no industry name for this device) KOOO 6{73 - Equivalent to legally marketed devices ( K973543 ) Kronner Prototypes, Inc. K coo 663 Description: The Kronner Low Profile Scope Holder with Electronic Control… | 1998 |
What descends from it? (2)
2 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 5 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K090792 (Mitaka Kohki Co., Ltd., 2009) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K973543.
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?
For abdominal and thoracic endoscopic surgical procedures For abdominal and thoracic endoscopic and arthroscopic surgical procedures For abdominal and thoracic endoscopic surgical procedures For abdominal, thoracic, arthroscopic, endoscopic surgery and holding manual surgical instruments For abdominal, thoracic, arthroscopic, nasal endoscopic surgical procedures and holding manual surgical instruments For abdominal, thoracic, arthroscopic, nasal…
Read the full statement (88 words)
For abdominal and thoracic endoscopic surgical procedures
For abdominal and thoracic endoscopic and arthroscopic surgical procedures
For abdominal and thoracic endoscopic surgical procedures
For abdominal, thoracic, arthroscopic, endoscopic surgery and holding manual surgical instruments
For abdominal, thoracic, arthroscopic, nasal endoscopic surgical procedures and holding manual surgical instruments
For abdominal, thoracic, arthroscopic, nasal endoscopic surgical procedures and holding manual surgical instruments
For nasal endoscopic surgical procedures
For nasal endoscopic surgical procedures and holding manual surgical instruments
*Tolerates pressures to 150 PSI, do not use with pressures over 150 psi.
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/K000663 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000663: Kronner Low Profile Scope Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000663
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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