# K960915: Clarus Neuropen Endoscopic Placement Kit Model 2125-XXX

- Pathway: 510(k) (Traditional)
- Applicant: Clarus Medical Systems, Inc.
- Decided: Dec 24, 1996 after 293 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Model 2120 NeuroPen Endoscope by Clarus Medical: named in the summary without a submission number
- (no number) Model 2125 MurphyScope by Clarus Medical: named in the summary without a submission number
- (no number) Catalog No. 82-6570 NEUROGUIDE Endoscopic Shunt Placement Kit by J & J: named in the summary without a submission number

## Indications for use
The Clarus Model 2121-XXX NeuroPEN Endoscopic Shunt Placement Kit is intended for endoscopic intraoperative intracranial neurosurgical shunt placement procedures where cerebrospinal fluid (CSF) may be contacted. The endoscope and the shunt are supplied sterile and are intended for single use.

Source page: https://510kreport.com/device/K960915
Methodology: https://510kreport.com/methodology