# K201118: Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: May 26, 2020 after 29 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K920156 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983799: Medtronic PS Medical Niveau Drainage System, Medtronic PS Medical Niveau Drainage System Pole Clamp, Medtronic PS Medicl, Medtronic PS Medical (1999) Summary page 5.

## Indications for use
Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to: 1. Reduce ICP, e.g., pre-, intra- or postoperative. 2. Monitor CSF chemistry, cytology, and physiology. 3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts. Monitoring of ICP is indicated in selected patients with: 1. Severe head injury. 2. Subarachnoid hemorrhage graded III, IV or V preoperatively. 3. Reyes syndrome or similar encephalopathies. 4. Hydrocephalus. 5. Intracranial hemorrhage. 6. Miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre- and postoperatively for space-occupying lesions.

Source page: https://510kreport.com/device/K201118
Methodology: https://510kreport.com/methodology