Neurosurgical Drills: Stille, Hudson
by Zinnanti Surgical Instruments, Inc.
510(k) K892531
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK892531 | Date5 May 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HBG
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4300
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
Neurosurgical drills are manual instruments used for drilling in neurosurgical procedures. These devices are designed for precision in neurosurgical applications, including Stille and Hudson models.
The device is supplied as a non-sterile, reusable instrument. It is not MRI compatible and should be stored according to manufacturer instructions. The device has FDA 510(k) clearance with product code HBG and is classified under Drills, Burrs, Trephines & Accessories (Manual).
Other devices from Zinnanti Surgical Instruments, Inc.
Questions
AI-generated answers, 6 Oct 2026
What are neurosurgical drills Stille Hudson used for?
Neurosurgical drills Stille Hudson are manual instruments designed for precision drilling in neurosurgical procedures. They are specifically engineered for neurosurgical applications to ensure accuracy during surgical interventions.
How are these neurosurgical drills supplied and are they sterile?
The neurosurgical drills are supplied as non-sterile, reusable instruments. They require proper sterilization before each use according to standard medical protocols, as they are not provided in a sterile state by the manufacturer.
What is the regulatory status of these neurosurgical drills?
These neurosurgical drills have FDA 510(k) clearance with product code HBG and are classified under Drills, Burrs, Trephines & Accessories (Manual). They are substantially equivalent to predicate devices and are intended for manual use in neurosurgical procedures.
Are these neurosurgical drills MRI compatible?
No, these neurosurgical drills are not MRI compatible. They should not be used in MRI environments as they may interfere with the imaging process or pose safety risks in such settings.
How should these neurosurgical drills be stored?
These neurosurgical drills should be stored according to the manufacturer's instructions. Proper storage conditions help maintain the instrument's functionality and longevity between uses.