# K992591: Codman Single and Double Lumen Skull Bolt Kits

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Oct 15, 1999 after 74 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) CODMAN® MICROSENSOR™ Skull Bolt Kit: named in the summary without a submission number
- (no number) CAMINO Micro Ventricular Bolt Pressure Monitoring Kit: named in the summary without a submission number

## Most influential descendants
- K032337: Hemedex Cranial Bolt Models, 3601, 3602 (2003), 1 descendant of its own
- K141869: Qflow 500 Titanium Bolt, Quad Lumen Bolt Kit (2014), 0 descendants of its own

## Indications for use
The CODMAN® Single Lumen Skull Bolt Kit is designed to achieve cranial access and to introduce and secure a sensor in place for intracranial monitoring applications. The CODMAN® Double Lumen Skull Bolt Kit is designed to achieve cranial access and to introduce and secure Sensors in place for intracranial monitoring applications.

Source page: https://510kreport.com/device/K992591
Methodology: https://510kreport.com/methodology