510(k) · Cleared
Cleared3 Dimensional Video Endoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oktas · GCJ Laparoscope, General & Plastic Surgery
Cleared on Apr 14, 1997 as substantially equivalent to K923160 (American Surgical Technologies Corp., 1992) and 3 other predicates after an 83-day review. Its family tree reaches back 2 generations to 1992. 42 later devices descend from it.
- Decided
- Apr 14, 1997
- Review
- 83 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K923160 (1992). 4 ancestors in all. 42 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK923160 3DSCOPEAmerican Surgical Technologies Corp. · 1992
- 1 generation backK961182 3D ScopeOktas · 1996
- This deviceK970214 3 Dimensional Video EndoscopeOktas · 1997
- Descendant · cites it directly · 41 of its ownK990635 Vista Stereoscope SystemVista Medical Technologies, Inc. · 1999
- Descendant · 2 generations on · 37 of its ownK082355 Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008
- Descendant · 3 generations on · 36 of its ownK141002 VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2014
- Descendant · 4 generations on · 34 of its ownK152204 VS3-IR systemVisionsense, Ltd. · 2015
- Descendant · 5 generations on · 32 of its ownK162882 KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K990635Vista Stereoscope SystemVista Medical Technologies, Inc. · 1999 · cites it directly41descendants
- K082355Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008 · 2 generations on37descendants
- K141002VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2014 · 3 generations on36descendants
- K152204VS3-IR systemVisionsense, Ltd. · 2015 · 4 generations on34descendants
- K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017 · 5 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923160 | 3DSCOPE | American Surgical Technologies Corp. | 1992 | — |
| −1 | K961182 | 3D Scope | Oktas | 1996 | — |
| 0 (this device) | K970214 | 3 Dimensional Video Endoscope | Oktas | 1997 | — |
| +1 | K990635 | Vista Stereoscope System | Vista Medical Technologies, Inc. | 1999 | — |
| +2 | K082355 | Visionsense Stereoscopic Vision System | Visionsense, Ltd. | 2008 | — |
| +3 | K141002 | VS3 Stereoscopic High Definition Vision System | Visionsense, Ltd. | 2014 | — |
| +4 | K152204 | VS3-IR system | Visionsense, Ltd. | 2015 | — |
| +5 | K162882 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 8 | 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? (4)
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 |
|---|---|---|---|
| * | K923160 | 3DSCOPESummary page 1…al VideoSystem Classification: Camera, Television, Endoscopic, without audio Manufacturer: American Surgical Technologies 300 Billerica Rd Chelmsford, MA 01824 510(k) #: K923160 and K961182 2. Device Name: Oktas Video Endoscope System with Zoom Classification: Endoscopes and Accessories - 21 CFR 876.1500 M… | 1992 |
| * | K961182 | 3D ScopeSummary page 1…em Classification: Camera, Television, Endoscopic, without audio Manufacturer: American Surgical Technologies 300 Billerica Rd Chelmsford, MA 01824 510(k) #: K923160 and K961182 2. Device Name: Oktas Video Endoscope System with Zoom Classification: Endoscopes and Accessories - 21 CFR 876.1500 Manufacturer:… | 1996 |
| * | K946171 | Video Endoscope System with ZoomSummary page 1…: Oktas Video Endoscope System with Zoom Classification: Endoscopes and Accessories - 21 CFR 876.1500 Manufacturer: Oktas 134 Flanders Rd Westborough, MA 01581 510(k) #: K946171 Page 1 of 2 510(k) 38 Vista Medical Technologies 510(k) Notification Westborough, MA 3Dimensional Video Endosc… | 1995 |
| * | K950985 | Zeiss Endolive Stero Endoscope Our OCR of the scanned summary read K950988, FDA’s number for Holter 6000 (Omega Medical Services, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Zeiss EndoLive™ Stereo Endoscope”. | 1995 |
What descends from it? (42)
See all 421 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990635 | Vista Stereoscope System | 1999 | 41 |
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 3.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K990635 (Vista Medical Technologies, Inc., 1999) has gone furthest, with 41 descendants of its own.
- 3 other devices also cite its predicate K923160.
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 device is intended for use in all types of endoscopic and endoscopic assisted procedures, including general thoracic and as an aid in visualization of the evacuated cardiac chamber.
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/K970214 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970214: 3 Dimensional Video Endoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970214
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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