510(k) · Cleared
Recalled · Class II · 2026Aesculap Minop System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · GWG Endoscope, Neurological
Cleared on Dec 18, 1998 after an 85-day review. The FDA summary names its predicate without a number. 12 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 18, 1998
- Review
- 85 days
- Class
- Class II
- Product code
- GWG
- Recalls
- 3
- Predicates
- 0
12 later devices descend from it, 3 citing it directly.
- This deviceK983365 Aesculap Minop SystemAesculap, Inc. · 1998
- Descendant · cites it directly · 5 of its ownK132931 Apollo SystemPenumbra, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK182211 Aurora Surgiscope SystemRebound Therapeutics Corporation · 2019
- Descendant · 2 generations on · 4 of its ownK152699 Apollo SystemPenumbra, Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK191861 Aurora Surgiscope SystemRebound Therapeutics · 2019
- Descendant · 3 generations on · 2 of its ownK201840 Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System…Rebound Therapeutics · 2020 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K132931Apollo SystemPenumbra, Inc. · 2014 · cites it directly5descendants
- K182211Aurora Surgiscope SystemRebound Therapeutics Corporation · 2019 · cites it directly4descendants
- K152699Apollo SystemPenumbra, Inc. · 2016 · 2 generations on4descendants
- K191861Aurora Surgiscope SystemRebound Therapeutics · 2019 · 2 generations on3descendants
- K201840Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)Rebound Therapeutics · 2020 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983365 | Aesculap Minop System | Aesculap, Inc. | 1998 | — |
| +1 | K132931 | Apollo System | Penumbra, Inc. | 2014 | — |
| +1 | K182211 | Aurora Surgiscope System | Rebound Therapeutics Corporation | 2019 | — |
| +2 | K152699 | Apollo System | Penumbra, Inc. | 2016 | — |
| +2 | K191861 | Aurora Surgiscope System | Rebound Therapeutics | 2019 | — |
| +3 | K201840 | Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control… | Rebound Therapeutics | 2020 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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? (5)
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 |
|---|---|---|---|
| * | — | Aesculap Ventriculopscope Named without a submission number | |
| * | — | Aesculap Angled Neuroendoscopes Named without a submission number | |
| * | — | Codman Neuroendoscopes Named without a submission number | |
| * | — | Neuro Navigational Neuroview Named without a submission number | |
| * | — | Richard Wolf Neuro-Endoscope Named without a submission number |
What descends from it? (12)
See all 123 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 15, 2026 | Class II | Z-1485-2026 | Under Investigation by firm | There is the potential for the length of the trocar shaft to be too long. |
| Jul 20, 2023 | Class II | Z-2518-2023 | Process change control | Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured. |
| Mar 7, 2017 | Class II | Z-1814-2017 | Nonconforming Material/Component | Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on the distal end which may lead to the abrasion of the insulation when removing the electrode. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K132931 (Penumbra, Inc., 2014) has gone furthest, with 5 descendants of its own.
How does its category compare?
All GWG devicesGWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Aesculap’s MINOP System is indicated for use in endoscope-assisted microneurosurgery and pure neuroendoscopy (i.e. ventriculoscopy) for direct visualization, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.
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/K983365 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983365: Aesculap Minop System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983365
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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