510(k) · Cleared
ClearedIntuitive Surgical Stero View Endoscopic System
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 Feb 28, 2002 as substantially equivalent to K990188 (Intuitive Surgical, Inc., 1999) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Feb 28, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K943307 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK943307 3D Surgical Endoscopy System for General SurgeryOlympus America, Inc. · 1995
- 1 generation backK990188 Intuitive Surgical Stereo View Endoscopic System, Model SVS-1Intuitive Surgical, Inc. · 1999 · Recalled
- This deviceK013952 Intuitive Surgical Stero View Endoscopic SystemIntuitive Surgical, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943307 | 3D Surgical Endoscopy System for General Surgery | Olympus America, Inc. | 1995 | — |
| −1 | K990188 | Intuitive Surgical Stereo View Endoscopic System, Model SVS-1 | Intuitive Surgical, Inc. | 1999 | 1 |
| 0 (this device) | 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 |
| 2000 | 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 |
|---|---|---|---|
| * | K990188 | Intuitive Surgical Stereo View Endoscopic System, Model SVS-1Summary page 1…ope/Accessories 21 CFR §884.1720 Common Name: 3-D Endoscope and Accessories Predicate Intuitive Surgical® Stereo View Endoscopic System Devices (legally marketed under K990188 and K001666) Intuitive Surgical'D Stereo View Endoscopic System 510(k) Submission 8 Device Description Intended… | 1999 |
| * | K001666 | Modification to Intuitive Surgical Stereo View Endoscopic SystemSummary page 1…ies 21 CFR §884.1720 Common Name: 3-D Endoscope and Accessories Predicate Intuitive Surgical® Stereo View Endoscopic System Devices (legally marketed under K990188 and K001666) Intuitive Surgical'D Stereo View Endoscopic System 510(k) Submission 8 Device Description Intended Use ‘Compa… | 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 7 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
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 surgery sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed for use with the Intuitive Surgical® Endoscopic Instrument Control system during laparoscopic and thoracoscopic 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/K013952 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013952: Intuitive Surgical Stero View Endoscopic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013952
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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