HAD · Rongeur, Powered
Neurology · 21 CFR 882.4845 · Class 2
Overview
| Product Code | HAD |
|---|---|
| Device Name | Rongeur, Powered |
| Regulation | 21 CFR 882.4845 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
A powered rongeur is a powered instrument used for cutting or biting bone during surgery involving the skull or spinal column.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K062413 | AESCULAP PNEUMATIC KERRISON | Aesculap, Inc. | Nov 21, 2006 | SESE |
| K022907 | ANSPACH POWERED KERRISON SYSTEM (PKS) | The Anspach Effort, Inc. | Oct 21, 2002 | SESE |
| K911637 | STAYFREE, UNSCENTED/SCENTED/SCENTED DEODOR MEN PAD | Personal Products Co. | Aug 2, 1991 | SESE |
Top Applicants
- Aesculap, Inc. — 1 clearance
- Personal Products Co. — 1 clearance
- The Anspach Effort, Inc. — 1 clearance
