# K961113: CNS Interchangeable Bit Cranial Drill

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Neuro Systems, LLC
- Decided: Jun 5, 1996 after 77 days
- Product code: HBG (Drills, Burrs, Trephines & Accessories (Manual))
- Device class: 2
- Regulation: 21 CFR 882.4300
- Recalls of this device: 39 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 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) PS Medical Ventriculostomy Kit: Cranial Drill: named in the summary without a submission number
- (no number) Camino Laboratories Twist Drill Procedure Kit: Cranial Drill: named in the summary without a submission number
- (no number) Clinical Neuro Systems Cranial Drill: named in the summary without a submission number

## Most influential descendants
- K122456: Mrii Crainial Drill (2013), 4 descendants of its own
- K151536: SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm (2015), 2 descendants of its own
- K160129: MRII Cranial Drill and Accessories (2016), 1 descendant of its own
- K252696: Legacy (2025), 0 descendants of its own
- K252514: Evac-Mri (2025), 0 descendants of its own

## Recalls of this device
- Apr 17, 2024 · Class II · Z-1873-2024: Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
- Jan 19, 2024 · Class II · Z-1197-2024: A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Jan 19, 2024 · Class II · Z-1199-2024: A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Jan 19, 2024 · Class II · Z-1201-2024: A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Jan 19, 2024 · Class II · Z-1200-2024: A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Jan 19, 2024 · Class II · Z-1196-2024: A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Jan 19, 2024 · Class II · Z-1194-2024: A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Jan 19, 2024 · Class II · Z-1203-2024: A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Jan 19, 2024 · Class II · Z-1195-2024: A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Jan 19, 2024 · Class II · Z-1193-2024: A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Jan 19, 2024 · Class II · Z-1198-2024: A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Jan 19, 2024 · Class II · Z-1202-2024: A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Oct 19, 2023 · Class II · Z-0492-2024: Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device
- Oct 19, 2023 · Class II · Z-0493-2024: Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
- Oct 19, 2023 · Class II · Z-0494-2024: Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
- Oct 19, 2023 · Class II · Z-0495-2024: Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
- Oct 19, 2023 · Class II · Z-0496-2024: Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
- Oct 19, 2023 · Class II · Z-0491-2024: Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device
- Oct 19, 2023 · Class II · Z-0499-2024: Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
- Oct 19, 2023 · Class II · Z-0497-2024: Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
- Oct 19, 2023 · Class II · Z-0498-2024: Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
- Aug 24, 2016 · Class II · Z-2733-2016: Integra LifeSciences has been notified of a medical device recall by Adaptive Surgical, LLC involving their Riverlon" Nylon 3-0 Sutures that are packaged in Integras Cranial Access Kits. It was found
- Sep 4, 2013 · Class II · Z-2260-2013: Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the sterile package may become compromised during shipping.
- Dec 21, 2011 · Not classified · Z-0749-2012: Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
- Dec 21, 2011 · Not classified · Z-0750-2012: Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
- Dec 21, 2011 · Not classified · Z-0752-2012: Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
- Dec 21, 2011 · Not classified · Z-0756-2012: Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
- Dec 21, 2011 · Not classified · Z-0757-2012: Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
- Dec 21, 2011 · Not classified · Z-0748-2012: Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
- Dec 21, 2011 · Not classified · Z-0751-2012: Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
- Dec 21, 2011 · Not classified · Z-0755-2012: Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
- Dec 21, 2011 · Not classified · Z-0758-2012: Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
- Dec 21, 2011 · Not classified · Z-0759-2012: Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
- Dec 21, 2011 · Not classified · Z-0753-2012: Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
- Dec 21, 2011 · Not classified · Z-0754-2012: Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
- Feb 22, 2011 · Not classified · Z-2194-2011: Outer packaging of Combo Kit was mislabeled with an incorrect lot number.
- Feb 22, 2011 · Not classified · Z-2171-2011: Outer box of Monitoring Kit was mislabeled with the incorrect part number.
- Jul 13, 2009 · Not classified · Z-2084-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Mar 19, 2003 · Not classified · Z-1097-04: The outer labeling of the convenience kit indicates that an additional bottle of Sodium Chloride (saline) solution is included in the Custom Kit 31176; however, an additional bottle of 1% Xylocaine wa

## Indications for use
The drill is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP. The drill is intended for single use only.

Source page: https://510kreport.com/device/K961113
Methodology: https://510kreport.com/methodology