510(k) · Cleared
ClearedKarl Storz Endovision XL Endoscopic Camera System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz Imaging, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jan 30, 1998 as substantially equivalent to K950862 (Karl Storz Imaging, Inc., 1995) and 1 other predicate after a 70-day review. Its family tree reaches back 1 generation to 1988. 4 later devices descend from it.
- Decided
- Jan 30, 1998
- Review
- 70 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K883943 (1988). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK883943 CCM-1 Video Camera SystemMedical Concepts, Inc. · 1988
- This deviceK974391 Karl Storz Endovision XL Endoscopic Camera SystemKarl Storz Imaging, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK020336 Endoscopic Camera MC404/C3World of Medicine Lemke GmbH · 2002
- Descendant · cites it directly · 0 of its ownK080809 Iec Medsight and MedbrightInnovative Endoscopy Components, LLC · 2008
- Descendant · 2 generations on · 0 of its ownK032544 VP-1000; Med Cam 100; VP-3000A; Med Cam 300Mgb Endoskopische Gerate GmbH (Berlin) · 2003
- Descendant · cites it directly · 0 of its ownK991416 Endoscopic CameraGenzyme Surgical Product (Genzyme Biosurgery) · 1999
Most influential descendants
Showing 4 of 4 · See all- K020336Endoscopic Camera MC404/C3World of Medicine Lemke GmbH · 2002 · cites it directly1descendant
- K080809Iec Medsight and MedbrightInnovative Endoscopy Components, LLC · 2008 · cites it directly0descendants
- K032544VP-1000; Med Cam 100; VP-3000A; Med Cam 300Mgb Endoskopische Gerate GmbH (Berlin) · 2003 · 2 generations on0descendants
- K991416Endoscopic CameraGenzyme 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 | K883943 | CCM-1 Video Camera System | Medical Concepts, Inc. | 1988 | — |
| 0 (this device) | K974391 | Karl Storz Endovision XL Endoscopic Camera System | Karl Storz Imaging, Inc. | 1998 | — |
| +1 | K020336 | Endoscopic Camera MC404/C3 | World of Medicine Lemke GmbH | 2002 | — |
| +1 | K080809 | Iec Medsight and Medbright | Innovative Endoscopy Components, LLC | 2008 | — |
| +2 | K032544 | VP-1000; Med Cam 100; VP-3000A; Med Cam 300 | Mgb Endoskopische Gerate GmbH (Berlin) | 2003 | — |
| +1 | K991416 | Endoscopic Camera | Genzyme Surgical Product (Genzyme Biosurgery) | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K950862 | Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color Television…Summary page 2…on XL endoscopic camera system, is substantially equivalent to several other systems currently on the market including the KSI Tricam Color Endoscogic Television System (K950862) and the KSI Telecam Color Endoscopic Television System (K883943). The proposed new KSI Endovision XL is unique only in thatitisa… | 1995 |
| * | K883943 | CCM-1 Video Camera SystemSummary page 2…veral other systems currently on the market including the KSI Tricam Color Endoscogic Television System (K950862) and the KSI Telecam Color Endoscopic Television System (K883943). The proposed new KSI Endovision XL is unique only in thatitisa smaller, lighter, more portable camera system. Signed: _\ a‘mfi/… | 1988 |
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?
The Karl Storz Imaging (KSI) Endovision XL Camera System is a color, television camera system designed for attachment to endoscopic visioning systems.
The camera head is suitable for atachment to any rigid or flexible endoscope, including, such as sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledoscopes, nreteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope with a V-mount adapter. The camera is connected to the video processor via cable. The endoscopic image can be displayed on any standard operating room video monitor.
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/K974391 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974391: Karl Storz Endovision XL Endoscopic Camera System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974391
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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