Brain Biopsy Needle
by Ad-Tech Medical Instrument Corp.
510(k) K112094
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK112094 | Date24 Apr 2012 | 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- Withdrawn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
- HAW
- FDA applicant
- Ad-Tech Medical Instrument Corp
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Brain Biopsy Needle is a surgical instrument classified as a biopsy needle under the FDA’s product code HAW, designed for obtaining tissue samples from the brain. It is intended for use in neurosurgical procedures where precise tissue acquisition is required for diagnostic or research purposes.
This device is supplied as a single-use, disposable instrument, ensuring sterility and reducing the risk of cross-contamination. Authorized under FDA 510(k) clearance (K112094), it is intended for use in sterile operating room environments and adheres to traditional review standards. No MRI safety information is specified in the regulatory submission.
From the manufacturer
Ad-Tech Medical Instrument Corporation The World's Leader As the world leader, Ad-Tech's electrode devices are used in surgical cases for long-term EEG monitoring*, brain mapping, SEEG, and brain stimulation of persons with intractable epilepsy and other brain diseases/disorders. *Long Term Monitoring: Device use is indicated for up to 29 days.
Miscellaneous Products Brain Biopsy Needles Ad-Tech's disposable brain biopsy needles offer you a time- and cost-effective alternative to expensive reusable brain biopsy needles. Importantly, their single-use design addresses your concerns regarding cross-contamination and ensures that the needle will be straight and its cutting edges sharp.
Ad-Tech Brain Biopsy Needles -. Ad-Tech's disposable brain biopsy needles offer you a time and cost effective alternative to expensive reusable brain biopsy needles.
Other devices from Ad-Tech Medical Instrument Corp.
Questions
AI-generated answers, 18 Sep 2026
What types of neurosurgical procedures is this Brain Biopsy Needle designed for, and why is it considered single-use?
This Brain Biopsy Needle is specifically designed for obtaining tissue samples from the brain during neurosurgical procedures, primarily for diagnostic or research purposes. It is classified as single-use and disposable to ensure sterility and eliminate the risk of cross-contamination between patients, which is critical in sterile operating room environments like those used for brain surgeries.
How do I know if this device is compatible with my operating room setup, and what safety considerations should I keep in mind?
This Brain Biopsy Needle is intended for use in sterile operating room environments, as specified in its regulatory submission. While the device is not explicitly labeled as MRI-safe or unsafe, it is important to confirm compatibility with your facility’s MRI equipment if procedures involving imaging are planned. Always follow standard sterile technique protocols when using it, as it is designed for single-use only.
What regulatory pathway was followed for this device, and what does the advisory committee classification mean?
The Brain Biopsy Needle was cleared through the FDA’s 510(k) process under Traditional Review, with a decision code of SESE (Substantially Equivalent in Safety and Effectiveness). The advisory committee classification (NE – Neurology) indicates that the Neurology panel reviewed the submission, ensuring the device met standards relevant to neurosurgical instruments. This classification does not define its clinical use but confirms regulatory oversight by experts in the field.
Are there different sizes or models available for this Brain Biopsy Needle, and how should it be stored?
The provided data does not specify exact sizes or model variations for the Brain Biopsy Needle, so availability would need to be confirmed directly with Ad-Tech Medical Instrument Corp. However, since it is a single-use, disposable device, storage should follow manufacturer guidelines to maintain sterility—typically in a clean, dry environment away from direct sunlight or extreme temperatures until use.