510(k) · Cleared
ClearedTIPCAM 1S 3D System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz Endoscopy America, Inc. · GWG Endoscope, Neurological
Cleared on Mar 16, 2017 as substantially equivalent to K131434 (Visionsense, Ltd., 2013) after a 153-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Mar 16, 2017
- Review
- 153 days
- Class
- Class II
- Product code
- GWG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002431 (2000). 6 ancestors in all, the oldest K964281 (1997). No later device cites it as a predicate yet.
- Root · 4 generations backK002431 Elran 01 SystemEnvision Advanced Medical System, Ltd. · 2000
- 3 generations backK073279 VS-Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008
- 2 generations backK081102 Vsu - Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008 · Recalled
- 1 generation backK131434 VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2013
- This deviceK162880 TIPCAM 1S 3D SystemKarl Storz Endoscopy America, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002431 | Elran 01 System | Envision Advanced Medical System, Ltd. | 2000 | — |
| −3 | K073279 | VS-Visionsense Stereoscopic Vision System | Visionsense, Ltd. | 2008 | — |
| −2 | K081102 | Vsu - Visionsense Stereoscopic Vision System | Visionsense, Ltd. | 2008 | 1 |
| −1 | K131434 | VS3 Stereoscopic High Definition Vision System | Visionsense, Ltd. | 2013 | — |
| 0 (this device) | K162880 | TIPCAM 1S 3D System | Karl Storz Endoscopy America, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2013 | 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 GWG? 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 GWG device
- #1 K211202 1688 4K Camera System, L11 LED Light Source…score 22.5 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K131434 | VS3 Stereoscopic High Definition Vision SystemSummary page 4…ndoscopic Camera System Product Code: GWG Regulation: 21 CFR 882.1480 Predicate Device(s): VS3 Stereoscopic High Definition Vision System (K131434) Reference Device SPIES 3D System (K150525) Device Description: The TIPCAM®1S 3D System is intended for use durin… | 2013 |
| † | K150525 | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link | 2015 |
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 17 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 2 other devices also cite its predicate K131434.
How does its category compare?
All GWG devicesGWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · GWG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWG
269in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWG
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWG
33in 2025
MAUDE reports naming product code GWG, 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 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 2 | 4 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 19 |
| 2015 | 0 | — | 0 | 37 |
| 2016 | 2 | — | 0 | 25 |
| 2017 | 4 | 126 | 0 | 12 |
| 2018 | 4 | 128 | 0 | 16 |
| 2019 | 3 | 156 | 0 | 10 |
| 2020 | 2 | — | 0 | 19 |
| 2021 | 3 | 106 | 0 | 21 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 5 | 269 | 0 | 9 |
| 2024 | 1 | — | 0 | 9 |
| 2025 | 2 | — | 0 | 33 |
| 2026 | 4 | 217 | 0 | — |
What is it indicated for?
TIPCAM 1S 3D: The Rigid Videoendoscope is intended to be used together with the camera control unit for use in the visualization of ventricles and structures within the brain during neurological surgical procedures.
IMAGE 1S is a camera control unit (CCU) for use with camera heads of videoendoscopes for the visualization and documentation of endoscopic and microscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162880 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162880: TIPCAM 1S 3D System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162880
Report an extraction error
Are you the manufacturer?
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