Rongeur, Powered
The Powered Rongeur is a motorized neurosurgical instrument used to bite away and remove bone fragments during cranial or spinal procedures, providing more rapid and controlled bone removal than manual alternatives. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is HAD under regulation 21 CFR 882.4845 in the Neurology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- HAD
- Device Class
- FDA class 2
- Regulation Number
- 882.4845
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
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 |
|---|---|---|---|---|
| K062413 | AESCULAP PNEUMATIC KERRISON | Nov 21, 2006 | Substantially Equivalent | Aesculap, Inc. |
| K022907 | ANSPACH POWERED KERRISON SYSTEM (PKS) | Oct 21, 2002 | Substantially Equivalent | The Anspach Effort, Inc. |
| K911637 | STAYFREE, UNSCENTED/SCENTED/SCENTED DEODOR MEN PAD | Aug 02, 1991 | Substantially Equivalent | Personal Products Co. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.