Headrest, Neurosurgical
The Neurosurgical Headrest is a padded support used to position and cushion the patient's head during neurosurgical procedures, typically used for procedures not requiring rigid fixation, providing comfort and basic positional stability. It is classified as a Class 1 device (lowest risk), subject to general controls only. The product code is HBM under regulation 21 CFR 882.4440 in the Neurology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.
Research product code HBM in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- HBM
- Device Class
- FDA class 1
- Regulation Number
- 882.4440
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K911918 | SWIVEL HORSESHOE HEADREST | Jul 17, 1991 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K911917 | CODMAN PEDIATRIC HORSESHOE HEADREST | Jul 17, 1991 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K822169 | SURGICAL HEAD SUPPORT | Aug 20, 1982 | Substantially Equivalent | Kelleher Corp. |
FEI Numbers
This FDA classification entry is associated with 32 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 32 registration numbers. Click on an entry to view related FDA registrations.