# K973277: Caroline Guide/Delia Localizer

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Solutions, Inc.
- Decided: Nov 17, 1997 after 76 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Ventricular catheter stylette (pre-amendment device): named in the summary without a submission number

## Most influential descendants
- K981809: Caroline Guide (1998), 0 descendants of its own

## Indications for use
The Delia Localizer and Caroline Guide are indicated for use by neurosurgeons as shunt accessories for patients scheduled to undergo a posterior ventricular catheter placement procedure who are: 1) Adults 2) Have enlarged ventricles 3) Have normal scalp, skull, external ear and orbital anatomy 4) Do not have intracranial mass lesions or any structural abnormalities other than hydrocephalus 5) Have no general contraindications to surgery

Source page: https://510kreport.com/device/K973277
Methodology: https://510kreport.com/methodology