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 Jan 12, 1998 as substantially equivalent to K951854 (Leonard Medical, Inc., 1995) after a 116-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it.
- Decided
- Jan 12, 1998
- Review
- 116 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951854 (1995). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK951854 Leonard Arm - Support Arm - Endoscopic AccessoryLeonard Medical, Inc. · 1995
- This deviceK973543 Kronner Low Profile Scope HolderKronner Prototypes, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK000663 Kronner Low Profile Scope HolderKronner Prototypes, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK090792 Mitaka UniarmMitaka Kohki Co., Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK060085 Stryker Scope/Instrument HolderStryker Endoscopy · 2006
- Descendant · cites it directly · 0 of its ownK990062 SaphliftGenzyme Surgical Product (Genzyme Biosurgery) · 1999
Most influential descendants
Showing 4 of 4 · See all- K000663Kronner Low Profile Scope HolderKronner Prototypes, Inc. · 2000 · cites it directly2descendants
- K090792Mitaka UniarmMitaka Kohki Co., Ltd. · 2009 · cites it directly0descendants
- K060085Stryker Scope/Instrument HolderStryker Endoscopy · 2006 · 2 generations on0descendants
- K990062SaphliftGenzyme Surgical Product (Genzyme Biosurgery) · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951854 | Leonard Arm - Support Arm - Endoscopic Accessory | Leonard Medical, Inc. | 1995 | — |
| 0 (this device) | K973543 | Kronner Low Profile Scope Holder | Kronner Prototypes, Inc. | 1998 | — |
| +1 | K000663 | Kronner Low Profile Scope Holder | Kronner Prototypes, Inc. | 2000 | — |
| +1 | K090792 | Mitaka Uniarm | Mitaka Kohki Co., Ltd. | 2009 | — |
| +2 | K060085 | Stryker Scope/Instrument Holder | Stryker Endoscopy | 2006 | — |
| +1 | K990062 | Saphlift | Genzyme Surgical Product (Genzyme Biosurgery) | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K951854 | Leonard Arm - Support Arm - Endoscopic AccessorySummary page 4…ommon Name: Endoscope Holder Classification Name: Endoscope holding device, (no industry name for this device) Equivalent to legally marketed devices ( K951854 ) Leonard Arm Description: The Kronner Low Profile Scope Holder consists of mechanical linkages that connect bet… | 1995 |
What descends from it? (4)
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?
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, thoracic, arthroscopic and nasal endoscopic surgical procedures.
For abdominal, thoracic, arthroscopic endoscopic surgical procedures.
For nasal endoscopic surgical procedures.
For abdominal, thoracic, arthroscopic and nasal endoscopic surgical procedures.
For abdominal, thoracic, arthroscopic and nasal endoscopic surgical procedures.
For abdominal, thoracic, arthroscopic and nasal endoscopic surgical procedures.
For abdominal, thoracic, arthroscopic and nasal endoscopic surgical procedures.
For nasal endoscopic surgical procedures
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/K973543 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973543: Kronner Low Profile Scope Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973543
Report an extraction error
Are you the manufacturer?
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