510(k) · Cleared
ClearedConvivo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, AG · GWG Endoscope, Neurological
Cleared on Oct 25, 2018 as substantially equivalent to K180270 (Mauna Kea Technologies, 2018) after a 181-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Oct 25, 2018
- Review
- 181 days
- Class
- Class II
- Product code
- GWG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002788 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK002788 Ksea Neuro-FiberscopeKARL STORZ Endoscopy-America, Inc. · 2000 · Recalled
- 2 generations backK161112 KARL STORZ Flexible Video-Neuro-Endoscope SystemKARL STORZ Endoscopy-America, Inc. · 2016
- 1 generation backK180270 Cellvizio 100 Series Systems with Confocal MiniprobesMauna Kea Technologies · 2018
- This deviceK181116 ConvivoCarl Zeiss Meditec, AG · 2018
- Descendant · cites it directly · 0 of its ownK211156 CONVIVO In Vivo Pathology SuiteCarl Zeiss Meditec, AG · 2021
Most influential descendants
Showing 1 of 1 · See all- K211156CONVIVO In Vivo Pathology SuiteCarl Zeiss Meditec, AG · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002788 | Ksea Neuro-Fiberscope | KARL STORZ Endoscopy-America, Inc. | 2000 | 4 |
| −2 | K161112 | KARL STORZ Flexible Video-Neuro-Endoscope System | KARL STORZ Endoscopy-America, Inc. | 2016 | — |
| −1 | K180270 | Cellvizio 100 Series Systems with Confocal Miniprobes | Mauna Kea Technologies | 2018 | — |
| 0 (this device) | K181116 | Convivo | Carl Zeiss Meditec, AG | 2018 | — |
| +1 | K211156 | CONVIVO In Vivo Pathology Suite | Carl Zeiss Meditec, AG | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K180270 | Cellvizio 100 Series Systems with Confocal Miniprobes Cleared while this submission was under review Summary page 4…eurology Predicate Device: Cellvizio 100 Series System with Confocal Miniprobes™ (CranioFlex™ (-,-C) type Confocal Miniprobes™) (K180270) Reference Device: YELLOW 560 (K162991) Indications for Use The ZEISS CONVIVO is a surgical endomicroscope intended… | 2018 |
| † | K162991 | YELLOW 560 Fluorescence Module | 2017 |
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 |
|---|---|---|---|
| K211156 | CONVIVO In Vivo Pathology Suite | 2021 | 0 |
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 18 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K211156 (Carl Zeiss Meditec, AG, 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K180270.
How does its category compare?
All GWG devicesGWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
The ZEISS CONVIVO is a surgical endomicroscope intended for viewing intra-operative blood flow in the cerebral vascular area, including microvasculature and capillaries.
The CONVIVO’s fiber optic scanner probe is placed in direct contact with tissue during cranial diagnostic and therapeutic procedures, such as tumor biopsy and resection, to create in-vivo confocal laser scanning images of the internal microstructure of tissues.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181116: Convivo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181116
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