Chair, Neurosurgical
The Neurosurgical Chair is a specialized surgical chair designed to position patients appropriately for neurosurgical procedures, particularly those performed in the seated or semi-reclined position, and may include adjustment features to optimize surgical access. It is classified as a Class 1 device (lowest risk), subject to general controls only. The product code is HBN under regulation 21 CFR 882.4125 in the Neurology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.
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Basic Information
- Product Code
- HBN
- Device Class
- FDA class 1
- Regulation Number
- 882.4125
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K900472 | SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI | Sep 04, 1990 | Substantially Equivalent | Skytron, Div. the Kmw Group, Inc. |
| K822428 | SURGI-QUIP MICROSCOPE STAND | Sep 02, 1982 | Substantially Equivalent | Surgi-Quip Inc.U |
| K822426 | MCINTYRE MICROSCOPE STAND | Sep 02, 1982 | Substantially Equivalent | Surgi-Quip Inc.U |
| K822012 | BINOCULAR OPERATING MICROSCOPES & | Jul 30, 1982 | Substantially Equivalent | Kelleher Corp. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.