Dan Kerrison Rongeurs, Models K1 + Billy 1
by Dannoritzer Medical Instruments 510(k)
Active
510(k) K023868
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023868 | Date7 Feb 2003 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HAE
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4840
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Dan Kerrison Rongeurs, Models K1 and Billy 1, are manual surgical rongeurs designed for cutting or biting bone during cranial or spinal procedures. These instruments fall under the classification of manual rongeurs, providing precise mechanical action for bone resection in neurosurgical applications.
These rongeurs are intended for use in an operating room environment and are operated manually by clinicians. They are classified as Class II devices under FDA regulation number 882.4840, with a traditional 510(k) clearance through the Neurology Advisory Committee. The devices are reusable and not intended for MRI use.
Questions
AI-generated answers, 19 Sep 2026
Are these rongeurs suitable for use in MRI environments, and if not, why not?
No, the Dan Kerrison Rongeurs (Models K1 and Billy 1) are explicitly not intended for MRI use. This limitation is stated in the device description, meaning they should not be used in magnetic resonance imaging environments due to potential risks from magnetic fields or interference with imaging quality.
How are these rongeurs classified under FDA regulations, and what does that mean for their use?
The Dan Kerrison Rongeurs are classified as Class II devices under FDA regulation number 882.4840, which governs manual rongeurs. This classification means they undergo a traditional 510(k) clearance process through the Neurology Advisory Committee (NE) to demonstrate substantial equivalence to a predicate device. Clinically, this ensures they meet specific safety and performance standards for use in neurosurgical procedures like cranial or spinal bone resection.
Are these rongeurs single-use or reusable, and what does that imply for their maintenance?
The Dan Kerrison Rongeurs (Models K1 and Billy 1) are reusable instruments, as explicitly stated in the device description. This means they are designed for repeated use in the operating room after proper cleaning, sterilization, and maintenance. Reusability implies the need for adherence to strict infection control protocols, including autoclaving or other validated sterilization methods, to ensure safety between procedures.
What types of surgical procedures are these rongeurs primarily designed for?
These rongeurs are specifically designed for cutting or biting bone during cranial or spinal procedures, as described in the device details. Their precise mechanical action makes them suitable for neurosurgical applications where controlled bone resection is required, such as during decompressive surgeries or spinal fusions. They are not intended for soft tissue or non-neurosurgical uses.