510(k) K961113 ยท HBG Drills, Burrs, Trephines & Accessories (Manual)
CNS INTERCHANGEABLE BIT CRANIAL DRILL
| Applicant | Clinical Neuro Systems, LLC, Exton PA, US |
| Decision | Substantially Equivalent, Jun 5, 1996 |
| Received | Mar 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961113
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2024 | Integra LifeSciences Corp. Integra Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure.
Catalog Number: INS5HND Open, Classified |
HBG | None listed |
| Feb 28, 2024 | Integra 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 |
HBG | None listed |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | None listed |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | None listed |
| Feb 28, 2024 | Integra 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 |
HBG | None listed |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | None listed |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: INS7260 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | None listed |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: INS7270 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | None listed |
| Feb 28, 2024 | Integra LifeSciences Corp. INS7280 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | None listed |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: INSHITH / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | None listed |
| Feb 28, 2024 | Integra 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 |
HBG | None listed |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | None listed |
| Dec 6, 2023 | Integra 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 |
HBG | None listed |
| Dec 6, 2023 | Integra LifeSciences Corp. Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain.
Catalog Number: INS7270 Open, Classified |
HBG | None listed |
| Dec 6, 2023 | Integra LifeSciences Corp. Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain.
Catalog Number: INS7040 Open, Classified |
HBG | None listed |
| Dec 6, 2023 | Integra LifeSciences Corp. Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain.
Catalog Number: INS7280 Open, Classified |
HBG | None listed |
| Dec 6, 2023 | Integra LifeSciences Corp. Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain.
Catalog Number: INS7260 Open, Classified |
HBG | None listed |
| Dec 6, 2023 | Integra LifeSciences Corp. Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain.
Catalog Number: INS7250 Open, Classified |
HBG | None listed |
| Dec 6, 2023 | Integra LifeSciences Corp. Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain.
Catalog Number: HITHSP06 Open, Classified |
HBG | None listed |
| Dec 6, 2023 | Integra LifeSciences Corp. Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain.
Catalog Number: HITHSP04 Open, Classified |
HBG | None listed |
| Dec 6, 2023 | Integra 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 |
HBG | None listed |
| Sep 2, 2016 | Integra LifeSciences Corp. d.b.a. Integra Pain Management Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND Terminated |
HBG | None listed |
| Sep 19, 2013 | Integra 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 |
HGB | None listed |
| Jan 13, 2012 | Integra 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 |
HBG | None listed |
| Jan 13, 2012 | Integra 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 |
HBG | None listed |
| Jan 13, 2012 | Integra 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 |
HBG | None listed |
| Jan 13, 2012 | Integra 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 |
HBG | None listed |
| Jan 13, 2012 | Integra 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 |
HBG | None listed |
| Jan 13, 2012 | Integra 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 |
HBG | None listed |
| Jan 13, 2012 | Integra 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 |
HBG | None listed |
| Jan 13, 2012 | Integra 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 |
HBG | None listed |
| Jan 13, 2012 | Integra 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 |
HBG | None listed |
| Jan 13, 2012 | Integra 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 |
HBG | None listed |
| Jan 13, 2012 | Integra 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 |
HBG | None listed |
| Jan 13, 2012 | Integra 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 |
HBG | None listed |
| May 13, 2011 | Integra 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 |
HBG | None listed |
| May 10, 2011 | Integra 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 |
HBG | None listed |
| Sep 21, 2009 | Integra 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 |
HBG | None listed |
| Jul 20, 2004 | Integra 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 |
HCA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.