# K983365: Aesculap Minop System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Dec 18, 1998 after 85 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Aesculap Ventriculopscope: named in the summary without a submission number
- (no number) Aesculap Angled Neuroendoscopes: named in the summary without a submission number
- (no number) Codman Neuroendoscopes: named in the summary without a submission number
- (no number) Neuro Navigational Neuroview: named in the summary without a submission number
- (no number) Richard Wolf Neuro-Endoscope: named in the summary without a submission number

## Most influential descendants
- K132931: Apollo System (2014), 5 descendants of its own
- K182211: Aurora Surgiscope System (2019), 4 descendants of its own
- K152699: Apollo System (2016), 4 descendants of its own
- K191861: Aurora Surgiscope System (2019), 3 descendants of its own
- K201840: Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) (2020), 2 descendants of its own

## Recalls of this device
- Jan 15, 2026 · Class II · Z-1485-2026: There is the potential for the length of the trocar shaft to be too long.
- Jul 20, 2023 · Class II · Z-2518-2023: 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: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K983365
Methodology: https://510kreport.com/methodology