HBM · Headrest, Neurosurgical
Neurology · 21 CFR 882.4440 · Class 1
Overview
| Product Code | HBM |
|---|---|
| Device Name | Headrest, Neurosurgical |
| Regulation | 21 CFR 882.4440 |
| Device Class | Class 1 |
| Review Panel | Neurology |
Identification
A neurosurgical headrest is a device used to support the patient's head during a surgical procedure.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K911918 | SWIVEL HORSESHOE HEADREST | Codman & Shurtleff, Inc. | Jul 17, 1991 | SESE |
| K911917 | CODMAN PEDIATRIC HORSESHOE HEADREST | Codman & Shurtleff, Inc. | Jul 17, 1991 | SESE |
| K822169 | SURGICAL HEAD SUPPORT | Kelleher Corp. | Aug 20, 1982 | SESE |
Top Applicants
- Codman & Shurtleff, Inc. — 2 clearances
- Kelleher Corp. — 1 clearance
