510(k) · Cleared
Recalled · 2005Intuitive Surgical Stereo View Endoscopic System, Model SVS-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Apr 1, 1999 as substantially equivalent to K943307 (Olympus America, Inc., 1995) and 1 other predicate after a 71-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 1, 1999
- Review
- 71 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K943307 (1995). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK943307 3D Surgical Endoscopy System for General SurgeryOlympus America, Inc. · 1995
- This deviceK990188 Intuitive Surgical Stereo View Endoscopic System, Model SVS-1Intuitive Surgical, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK013952 Intuitive Surgical Stero View Endoscopic SystemIntuitive Surgical, Inc. · 2002
Most influential descendants
Showing 1 of 1 · See all- K013952Intuitive Surgical Stero View Endoscopic SystemIntuitive Surgical, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943307 | 3D Surgical Endoscopy System for General Surgery | Olympus America, Inc. | 1995 | — |
| 0 (this device) | K990188 | Intuitive Surgical Stereo View Endoscopic System, Model SVS-1 | Intuitive Surgical, Inc. | 1999 | — |
| +1 | K013952 | Intuitive Surgical Stero View Endoscopic System | Intuitive Surgical, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K943307 | 3D Surgical Endoscopy System for General Surgery Our OCR of the scanned summary read K943305, FDA’s number for Olympus 3D Surgical Endoscopy System (Olympus America, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Olympus 3D Surgical Endoscopy System”. | 1995 |
| * | K960637 | 5MM EndoscopeSummary page 1…n to the following predicate devices: Olympus 3D Surgical Endoscopy System ( Premarket Notification # K943305) Origin/Medsystems Smm Endoscope (Premarket Notification # K960637) 510(k) SUMMARY (Continued) Device Description: The Intuitive Surgical™ Stereo View System consists of an Intui… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013952 | Intuitive Surgical Stero View Endoscopic System | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 11, 2005 | Not classified | Z-1423-05 | Other | Customer complaints state the needle had separated from the hub, resulting in blood exposure and/or dislocation of the needle. |
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 Intuitive Surgical™ Stereo View Endoscopic System is intended for endoscopic viewing of internal surgical sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed to be used with the Intuitive Surgical™ Endoscopic Instrument Control System during thoracoscopic and laparoscopic 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/K990188 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990188: Intuitive Surgical Stereo View Endoscopic System, Model SVS-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990188
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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