ClearanceBrief
510(k) K961113 ยท HBG Drills, Burrs, Trephines & Accessories (Manual)

CNS INTERCHANGEABLE BIT CRANIAL DRILL

ApplicantClinical Neuro Systems, LLC, Exton PA, US
DecisionSubstantially Equivalent, Jun 5, 1996
ReceivedMar 20, 1996
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K961113

DateFirm and productCodeLinked 510(k)
May 20, 2024Integra LifeSciences Corp.
Integra Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Open, Classified
HBGNone listed
Feb 28, 2024Integra LifeSciences Corp.
Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain.
Open, Classified
HBGNone listed
Feb 28, 2024Integra LifeSciences Corp.
Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Open, Classified
HBGNone listed
Feb 28, 2024Integra LifeSciences Corp.
Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Open, Classified
HBGNone listed
Feb 28, 2024Integra LifeSciences Corp.
Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
Open, Classified
HBGNone listed
Feb 28, 2024Integra LifeSciences Corp.
Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Open, Classified
HBGNone listed
Feb 28, 2024Integra LifeSciences Corp.
Ref No: INS7260 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Open, Classified
HBGNone listed
Feb 28, 2024Integra LifeSciences Corp.
Ref No: INS7270 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Open, Classified
HBGNone listed
Feb 28, 2024Integra LifeSciences Corp.
INS7280 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Open, Classified
HBGNone listed
Feb 28, 2024Integra LifeSciences Corp.
Ref No: INSHITH / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Open, Classified
HBGNone listed
Feb 28, 2024Integra LifeSciences Corp.
Ref No: INSHITHND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
Open, Classified
HBGNone listed
Feb 28, 2024Integra LifeSciences Corp.
Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Open, Classified
HBGNone listed
Dec 6, 2023Integra LifeSciences Corp.
Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND
Open, Classified
HBGNone listed
Dec 6, 2023Integra LifeSciences Corp.
Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7270
Open, Classified
HBGNone listed
Dec 6, 2023Integra LifeSciences Corp.
Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
Open, Classified
HBGNone listed
Dec 6, 2023Integra LifeSciences Corp.
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7280
Open, Classified
HBGNone listed
Dec 6, 2023Integra LifeSciences Corp.
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260
Open, Classified
HBGNone listed
Dec 6, 2023Integra LifeSciences Corp.
Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7250
Open, Classified
HBGNone listed
Dec 6, 2023Integra LifeSciences Corp.
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06
Open, Classified
HBGNone listed
Dec 6, 2023Integra LifeSciences Corp.
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04
Open, Classified
HBGNone listed
Dec 6, 2023Integra LifeSciences Corp.
Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: 31004
Open, Classified
HBGNone listed
Sep 2, 2016Integra LifeSciences Corp. d.b.a. Integra Pain Management
Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
Terminated
HBGNone listed
Sep 19, 2013Integra LifeSciences Corp. d.b.a. Integra Pain Management
Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended
Terminated
HGBNone listed
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
1104HC Integra NeuroSciences Ventricular Bold Monitoring Kit W/ Cranial Access, Drain including (1) Cranial Kit W/Cam. Chuck, (1) Ventricular Bolt ICP Monitoring Kit, (1) CSF Drainage System. Contain
Terminated
HBGNone listed
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
Cranial Access Kit Ref INSHITH Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile,
Terminated
HBGNone listed
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
Cranial Access Kit Ref INSHITHNR Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile
Terminated
HBGNone listed
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
Cranial Access Kit Ref HITHSP04 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile,
Terminated
HBGNone listed
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
Cranial Access Kit Ref HITHSP06 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile,
Terminated
HBGNone listed
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
Cranial Access Kit Ref SP0153 Integra NeuroSciences Plainsboro, NJ 08536 Contents Sterile and non-sterile, Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO, Contents 5 units. Product Usage:
Terminated
HBGNone listed
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
1104LC Combo Kit including 1 Camino ICP Monitoring Catheter, 1 Cranial Kit w/Cam Chuck. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 South, West Valley City, Utah 84119. Product Usage:
Terminated
HBGNone listed
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
31147 Combo Kit W/110-4BT & 30361 including 1 Cranial Kit w/Cam Chuck 1 intracranial pressure & temperature monitoring kit, contains sterile and non-sterile product. Integra NeuroSciences, Integra Lif
Terminated
HBGNone listed
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
31144 Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 Micro Ventricular Bolt ICP, 1 CSF Drainage System, contains sterile and non-sterile product. Integra NeuroSciences, Integra LifeSciences 3498 Wes
Terminated
HBGNone listed
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
1104HMC Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 Micro Ventricular Bolt ICP Monitoring Kit, 1 CSF Drainage System, contains sterile and non-sterile product. Integra NeuroSciences, Integra Life
Terminated
HBGNone listed
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
1104BC Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 OLM Intracranial Pressure Monitoring Kit, contains sterile and non-sterile product. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 S
Terminated
HBGNone listed
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
Cranial Access Kit Ref HITHSP06 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile,
Terminated
HBGNone listed
May 13, 2011Integra LifeSciences Corp.
Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South, West Valley City, UT 84119. A kit for cranial access containing multiple necessary components to create the bu
Terminated
HBGNone listed
May 10, 2011Integra LifeSciences Corp.
Ventricular Bolt Monitoring Kit W/Cranial Access, Drain, 1104HMC, Integra LifeSciences, 3498 West 2400 South, West Valley City, Utah 84119. Kit contains components which are used to monitor Intra Cra
Terminated
HBGNone listed
Sep 21, 2009Integra Life Sciences Corporation
Hand Drill - Sterile, Disposable, Convenience Kit, Reorder Number INS030, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other product
Terminated
HBGNone listed
Jul 20, 2004Integra Life Sciences Corp.
Cranial Access Kit (INS-HITH) included in External CSF Drainage Kit convenience Kit #31176. The kit contains: one Hermetic Large Style Ventricular Catheter Set, one Ventricular Drainage System, one IN
Terminated
HCANone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.