Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed
The Reprocessed Simple Powered Neurological Drills, Burrs, Trephines and Accessories are reprocessed neurosurgical powered instruments used for cutting, drilling, or removing bone during cranial and neurosurgical procedures; reprocessing validation data must be included in a 510(k) submission. They are classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NLN and regulation 21 CFR 882.4310 in the Neurology specialty. The devices are eligible for third-party review and carry no implant or life-sustaining flags.
Basic Information
- Product Code
- NLN
- Device Class
- FDA class 2
- Regulation Number
- 882.4310
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K041978 | REPROCESSED DIAMOND BURS | Nov 23, 2004 | Substantially Equivalent | ALLIANCE MEDICAL CORP. |