510(k) · Cleared
Cleared3DSCOPE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Surgical Technologies Corp. · FWF Camera, Television, Endoscopic, Without Audio
Cleared on Dec 10, 1992 after a 164-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 52 later devices descend from it.
- Decided
- Dec 10, 1992
- Review
- 164 days
- Class
- Class I
- Product code
- FWF
- Recalls
- None
- Predicates
- 0
52 later devices descend from it, 4 citing it directly.
- This deviceK923160 3DSCOPEAmerican Surgical Technologies Corp. · 1992
- Descendant · cites it directly · 44 of its ownK961182 3D ScopeOktas · 1996
- Descendant · cites it directly · 42 of its ownK970214 3 Dimensional Video EndoscopeOktas · 1997
- Descendant · 2 generations on · 41 of its ownK990635 Vista Stereoscope SystemVista Medical Technologies, Inc. · 1999
- Descendant · 3 generations on · 37 of its ownK082355 Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008
- Descendant · 4 generations on · 36 of its ownK141002 VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2014
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K9611823D ScopeOktas · 1996 · cites it directly44descendants
- K9702143 Dimensional Video EndoscopeOktas · 1997 · cites it directly42descendants
- K990635Vista Stereoscope SystemVista Medical Technologies, Inc. · 1999 · 2 generations on41descendants
- K082355Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008 · 3 generations on37descendants
- K141002VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2014 · 4 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K923160 | 3DSCOPE | American Surgical Technologies Corp. | 1992 | — |
| +1 | K961182 | 3D Scope | Oktas | 1996 | — |
| +1 | K970214 | 3 Dimensional Video Endoscope | Oktas | 1997 | — |
| +2 | K990635 | Vista Stereoscope System | Vista Medical Technologies, Inc. | 1999 | — |
| +3 | K082355 | Visionsense Stereoscopic Vision System | Visionsense, Ltd. | 2008 | — |
| +4 | K141002 | VS3 Stereoscopic High Definition Vision System | Visionsense, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FWF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (52)
See all 524 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?
- Of its descendants, K961182 (Oktas, 1996) has gone furthest, with 44 descendants of its own.
How does its category compare?
All FWF devicesFWF Camera, Television, Endoscopic, Without Audio: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FWF
FDA has decided no FWF device since 2007.
Median 510(k) review, days · FWF
Too few FWF 510(k)s in any year since 2007 to give a median.
Recalls per year · FWF
2in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FWF
27in 2025
MAUDE reports naming product code FWF, 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 | 0 | — | 2 | 1 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 40 |
| 2020 | 0 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 28 |
| 2022 | 0 | — | 0 | 40 |
| 2023 | 0 | — | 0 | 25 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 27 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K923160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K923160: 3DSCOPE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923160
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026