STIMUPLEX, NERVE STIMULATOR— 510(k) K860126
Substantially EquivalentBurron Medical Products, Inc.
FDA 510(k) clearance K860126 for STIMUPLEX, NERVE STIMULATOR, Substantially Equivalent on 1986-02-28. Applicant: Burron Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Burron Medical Products, Inc.
- Product code
- Code BXN
- Device class
- Class 2
- Regulation
- 21 CFR 868.2775
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethlehem, PA, US
Recent devices under product code BXN
view allMore clearances from Burron Medical Products, Inc.
view allAdverse events under product code BXN
product code BXN- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K860126
K-number listed on FDA's recall record- Z-2131-2024 — Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.
- Z-2132-2024 — Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260
- Z-2133-2024 — Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278
- Z-2134-2024 — Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K860126.
Data sourced from openFDA. This site is unofficial and independent of the FDA.