Product code BXM— Anesthesiology

MODEL SKCK STERILE KNOB COVER KIT

Classification name: Stimulator, Nerve, Ac-Powered
Device class: Class 2
Regulation: 21 CFR 868.2775
Advisory panel: Anesthesiology
Total cleared: 4
First cleared: 1987-10-28
Most recent: 2001-10-16

Market context for product code BXM

FDA has cleared 4 devices under product code BXM between 1987 and 2001, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20011 clearance
20001 clearance
19931 clearance
19871 clearance

Top applicants under product code BXM

Nuvasive, Inc.2 clearances
Vermont Medical, Inc.1 clearance
Life-Tech Intl., Inc.1 clearance

Recent clearances under product code BXM

K013215 — MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEMNuvasive, Inc.·2001-10-16
K002677 — NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEMNuvasive, Inc.·2000-11-13
K921498 — VER MED A10011 PNS DUAL ELEMENT ELECTRODEVermont Medical, Inc.·1993-06-09
K870662 — MODEL SKCK STERILE KNOB COVER KITLife-Tech Intl., Inc.·1987-10-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.