Stimulator, Nerve, Ac-Powered
The Stimulator, Nerve, AC-Powered is an alternating current powered device that delivers electrical stimulation to peripheral nerves, used to locate nerves during regional anesthesia procedures or to assess neuromuscular blockade. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is BXM, regulated under 21 CFR 868.2775 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- BXM
- Device Class
- FDA class 2
- Regulation Number
- 868.2775
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K013215 | MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM | Oct 16, 2001 | Substantially Equivalent | Nuvasive, Inc. |
| K002677 | NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM | Nov 13, 2000 | Substantially Equivalent | Nuvasive, Inc. |
| K921498 | VER MED A10011 PNS DUAL ELEMENT ELECTRODE | Jun 09, 1993 | Substantially Equivalent | Vermont Medical, Inc. |
| K870662 | MODEL SKCK STERILE KNOB COVER KIT | Oct 28, 1987 | Substantially Equivalent | Life-Tech Intl., Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.