Atlas FDA

CNS INTERCHANGEABLE BIT CRANIAL DRILL

FDA 510(k) clearance K961113 · decided 1996-06-05

Clearance details

K-number
K961113
Device name
CNS INTERCHANGEABLE BIT CRANIAL DRILL
Applicant
Clinical Neuro Systems, LLC
Decision
Substantially Equivalent
Date received
1996-03-20
Decision date
1996-06-05
Days to decision
77 days
Clearance type
Traditional
Product code
HBG
Device class
2
Regulation number
882.4300
Medical specialty
Neurology
Advisory committee
Neurology
Location
Exton, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Integra Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventricul recall (Z-1873-2024)Integra LifeSciences Corp.2024-05-20
Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarach recall (Z-1193-2024)Integra LifeSciences Corp.2024-02-28
Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the recall (Z-1194-2024)Integra LifeSciences Corp.2024-02-28
Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the recall (Z-1195-2024)Integra LifeSciences Corp.2024-02-28
Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For a recall (Z-1196-2024)Integra LifeSciences Corp.2024-02-28
Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the recall (Z-1197-2024)Integra LifeSciences Corp.2024-02-28
Ref No: INS7260 / Integra Cranial Access Kit. For access to the subarachnoid space or the recall (Z-1198-2024)Integra LifeSciences Corp.2024-02-28
Ref No: INS7270 / Integra Cranial Access Kit. For access to the subarachnoid space or the recall (Z-1199-2024)Integra LifeSciences Corp.2024-02-28
INS7280 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral recall (Z-1200-2024)Integra LifeSciences Corp.2024-02-28
Ref No: INSHITH / Integra Cranial Access Kit. For access to the subarachnoid space or the recall (Z-1201-2024)Integra LifeSciences Corp.2024-02-28
Ref No: INSHITHND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For recall (Z-1202-2024)Integra LifeSciences Corp.2024-02-28
Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or t recall (Z-1203-2024)Integra LifeSciences Corp.2024-02-28
Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subara recall (Z-0491-2024)Integra LifeSciences Corp.2023-12-06
Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles recall (Z-0492-2024)Integra LifeSciences Corp.2023-12-06
Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricle recall (Z-0493-2024)Integra LifeSciences Corp.2023-12-06
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles recall (Z-0494-2024)Integra LifeSciences Corp.2023-12-06
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles recall (Z-0495-2024)Integra LifeSciences Corp.2023-12-06
Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles recall (Z-0496-2024)Integra LifeSciences Corp.2023-12-06
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles recall (Z-0497-2024)Integra LifeSciences Corp.2023-12-06
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles recall (Z-0498-2024)Integra LifeSciences Corp.2023-12-06
Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or th recall (Z-0499-2024)Integra LifeSciences Corp.2023-12-06
Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND recall (Z-2733-2016)Integra LifeSciences Corp. d.b.a. Integra Pain Management2016-09-02
Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The k recall (Z-2260-2013)Integra LifeSciences Corp. d.b.a. Integra Pain Management2013-09-19
1104HC Integra NeuroSciences Ventricular Bold Monitoring Kit W/ Cranial Access, Drain incl recall (Z-0748-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
Cranial Access Kit Ref INSHITH Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non- recall (Z-0749-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
Cranial Access Kit Ref INSHITHNR Integra NeuroSciences Plainsboro, NJ 08536 Sterile and no recall (Z-0750-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
Cranial Access Kit Ref HITHSP04 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non recall (Z-0751-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
Cranial Access Kit Ref HITHSP06 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non recall (Z-0752-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
Cranial Access Kit Ref SP0153 Integra NeuroSciences Plainsboro, NJ 08536 Contents Sterile recall (Z-0753-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
1104LC Combo Kit including 1 Camino ICP Monitoring Catheter, 1 Cranial Kit w/Cam Chuck. In recall (Z-0754-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
31147 Combo Kit W/110-4BT & 30361 including 1 Cranial Kit w/Cam Chuck 1 intracranial press recall (Z-0755-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
31144 Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 Micro Ventricular Bolt ICP, 1 CSF D recall (Z-0756-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
1104HMC Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 Micro Ventricular Bolt ICP Monito recall (Z-0757-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
1104BC Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 OLM Intracranial Pressure Monitori recall (Z-0758-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
Cranial Access Kit Ref HITHSP06 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non recall (Z-0759-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-01-13
Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South, W recall (Z-2194-2011)Integra LifeSciences Corp.2011-05-13
Ventricular Bolt Monitoring Kit W/Cranial Access, Drain, 1104HMC, Integra LifeSciences, 34 recall (Z-2171-2011)Integra LifeSciences Corp.2011-05-10
Hand Drill - Sterile, Disposable, Convenience Kit, Reorder Number INS030, Integra LifeScie recall (Z-2084-2009)Integra Life Sciences Corporation2009-09-21
Cranial Access Kit (INS-HITH) included in External CSF Drainage Kit convenience Kit #31176 recall (Z-1097-04)Integra Life Sciences Corp.2004-07-20