# K153347: Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Aug 19, 2016 after 273 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K914479 (1994). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914479: Microsensor Intracranial Pressure Transducer, Codman & Shurtleff, Inc. (1994) Summary page 4.

## Most influential descendants
- K182073: BcSs-PICNI-2000 Sensor (2019), 2 descendants of its own
- K201989: B4C System (2021), 1 descendant of its own
- K250285: Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003); Neurovent-Ifd-S (091678-003); Neurovent-P-Temp (094268-003); Neurovent-Temp (094278-003); Neurovent-Temp-Ifd-R (095327-003); Neurovent-Temp-Ifd-S (094288-003); Neurovent-Pto (095008-003); Neurovent-Pto 2L (095108-003); Neurovent-PX (091580-003); Bolt-Drill Kit CH5 (091888-003); Bolt-Drill Kit CH9 (091898-003); Bolt-Drill Kit Pto (092380-003); Bolt-Drill Kit VP 16 (092969-003); Bolt Kit CH5 (091868-003); Bol (2025), 0 descendants of its own
- K240821: B4C System - Addition of new sensor model (BcSs-PICNIW-2000) (2024), 0 descendants of its own
- K173192: CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit (2017), 0 descendants of its own

## Recalls of this device
- Dec 12, 2025 · Class II · Z-1036-2026: Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.

## Indications for use
62-6631 Codman Microsensor Basic Kit: Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only. 62-6632 and 62-6638 Codman Microsensor Skull Bolt Kit (Plastic and Metal): Use of the CODMAN MICROSENSOR Plastic/Metal Skull Bolt Kit is indicated when direct intracranial pressure (ICP) monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications. 62-6633 Codman Microsensor Catheter Kit and 62-6653 Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter: Use of the Ventricular Catheter Kit is indicated when direct intraventricular pressure monitoring is required. The kit is indicated for use in ICP monitoring and cerebrospinal fluid (CSF) drainage applications.

Source page: https://510kreport.com/device/K153347
Methodology: https://510kreport.com/methodology