510(k) · Cleared

Cleared

KARL STORZ Flexible Video-Neuro-Endoscope System

K161112510(k) TraditionalCleared Sep 17, 2016150-day reviewClass II21 CFR 882.1480

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

KARL STORZ Endoscopy-America, Inc. · GWG Endoscope, Neurological

Cleared on Sep 17, 2016 as substantially equivalent to K002788 (KARL STORZ Endoscopy-America, Inc., 2000) after a 150-day review. Its family tree reaches back 1 generation to 2000. 6 later devices descend from it.

Decided: Sep 17, 2016
Review: 150 days
Class: Class II
Product code: GWG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K002788 (2000). 6 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK002788 Ksea Neuro-FiberscopeKARL STORZ Endoscopy-America, Inc. · 2000 · Recalled
This deviceK161112 KARL STORZ Flexible Video-Neuro-Endoscope SystemKARL STORZ Endoscopy-America, Inc. · 2016
Descendant · cites it directly · 5 of its ownK180270 Cellvizio 100 Series Systems with Confocal MiniprobesMauna Kea Technologies · 2018
Descendant · 2 generations on · 2 of its ownK191144 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2020
Descendant · 2 generations on · 1 of its ownK181116 ConvivoCarl Zeiss Meditec, AG · 2018
Descendant · 3 generations on · 0 of its ownK243711 Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe…Wuxi Hisky Medical Technologies Co., Ltd. · 2025
Descendant · 3 generations on · 0 of its ownK211156 CONVIVO In Vivo Pathology SuiteCarl Zeiss Meditec, AG · 2021

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2018high 2 (2018) · low 0 (2019)2026

Most influential descendants

Showing 5 of 6 · See all

K180270Cellvizio 100 Series Systems with Confocal MiniprobesMauna Kea Technologies · 2018 · cites it directly5descendants
K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2020 · 2 generations on2descendants
K181116ConvivoCarl Zeiss Meditec, AG · 2018 · 2 generations on1descendant
K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd. · 2025 · 3 generations on0descendants
K211156CONVIVO In Vivo Pathology SuiteCarl Zeiss Meditec, AG · 2021 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002788	Ksea Neuro-Fiberscope	KARL STORZ Endoscopy-America, Inc.	2000	4
0 (this device)	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	—
+2	K191144	Cellvizio 100 Series System with Confocal Miniprobes	Mauna Kea Technologies	2020	—
+2	K181116	Convivo	Carl Zeiss Meditec, AG	2018	—
+3	K243711	Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging…	Wuxi Hisky Medical Technologies Co., Ltd.	2025	—
+3	K211156	CONVIVO In Vivo Pathology Suite	Carl Zeiss Meditec, AG	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	2	0
2020	1	0
2021	2	0
2025	1	0

FIG. 1 — Lineage of K161112, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K002788	Ksea Neuro-Fiberscope Summary page 4 …Not Applicable for GWG product code Consensus Standards: Predicate Predicate Device: KARL STORZ Endoscopy-America’s KSEA Device(s): Neuro-Fiberscope (K002788) The predicate device has not been subject to a design-related recall. Device The Flexible Video-Ne…	KARL STORZ Endoscopy-America, Inc.	2000	4

Also cleared against K002788: 1 other device →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K180270	Cellvizio 100 Series Systems with Confocal Miniprobes	Mauna Kea Technologies	2018	5

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?

Its one ancestor has a recall.
Of its descendants, K180270 (Mauna Kea Technologies, 2018) has gone furthest, with 5 descendants of its own.
1 other device also cites its predicate K002788.

How does its category compare?

All GWG devices

GWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · GWG

2in 2025

2007high 5 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWG

269in 2023

2007high 269 (2023) · low 106 (2021)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GWG

2in 2011

2007high 2 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GWG

33in 2025

2007high 37 (2015) · low 0 (2009)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 KARL STORZ Flexible Video-Neuro-Endoscope System is indicated to provide visualization and access during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection, hydrocephalus treatment, endoscopic third ventriculostomy with choroid plexus cauterization (ETV/CPC), endoscopic third ventriculostomy, cyst fenestration, and aqueduct exploration.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K161112 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161112: KARL STORZ Flexible Video-Neuro-Endoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161112

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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