CNS INTERCHANGEABLE BIT CRANIAL DRILL— 510(k) K961113
Substantially EquivalentClinical Neuro Systems, LLC
FDA 510(k) clearance K961113 for CNS INTERCHANGEABLE BIT CRANIAL DRILL, Substantially Equivalent on 1996-06-05. Applicant: Clinical Neuro Systems, LLC. Device class: 2.
Clearance details
- Applicant
- Clinical Neuro Systems, LLC
- Product code
- Code HBG
- Device class
- Class 2
- Regulation
- 21 CFR 882.4300
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Exton, PA, US
Recent devices under product code HBG
view allMore clearances from Clinical Neuro Systems, LLC
view allRecalls naming K961113
K-number listed on FDA's recall record- Z-1873-2024 — Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
- Z-1193-2024 — 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.
- Z-1194-2024 — Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
- Z-1195-2024 — Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
- Z-1196-2024 — 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.
- Z-1197-2024 — Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
- Z-1198-2024 — Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
- Z-1199-2024 — Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
- Z-1200-2024 — INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
- Z-1201-2024 — Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
- Z-1202-2024 — 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.
- Z-1203-2024 — Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
- Z-0491-2024 — 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
- Z-0492-2024 — Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7270
- Z-0493-2024 — Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
- Z-0494-2024 — Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7280
- Z-0495-2024 — Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260
- Z-0496-2024 — Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7250
- Z-0497-2024 — Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06
- Z-0498-2024 — Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K961113.
Data sourced from openFDA. This site is unofficial and independent of the FDA.