FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STIMUPLEX, NERVE STIMULATOR
K Number: K860126
·
Decision Feb 28, 1986
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
62
Applicant Total
41
Review Days
45
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Basic Information
- Device Name
- STIMUPLEX, NERVE STIMULATOR
- K Number
- K860126
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2775
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Burron Medical Products, Inc.
- Date Received
- January 14, 1986
- Decision Date
- February 28, 1986
- Product Code
- BXN
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BXN | Stimulator, Nerve, Battery-Powered | FDA class 2 | Anesthesiology |
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STIMPOD ST2-3010 NERVE STIMULATOR
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EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
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Other Clearances by Burron Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K870403 | CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE | May 1, 1987 | Substantially Equivalent |
| K862412 | INTESTOPLANT | Nov 13, 1986 | Substantially Equivalent |
| K861479 | CAVAFIX, CENTRAL VENOUS CATHETER KIT | Jul 1, 1986 | Unknown |
| K851293 | IMPLANTOFIX | Jan 9, 1986 | Substantially Equivalent |
| K841428 | JEJUNOSTOMY SET FOR TUBE FEEDING | Jul 9, 1984 | Substantially Equivalent |
| K834383 | DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT | May 1, 1984 | Substantially Equivalent |
| K834299 | LONG TERM CENTRAL VENOUS ACCESS CATH | May 1, 1984 | Substantially Equivalent |
| K834473 | MULTI-LUMEN CENTRAL VENOUS CATH. KIT | Apr 30, 1984 | Substantially Equivalent |
| K840179 | CONTINUOUS EPIDURAL ANESTHES. TRAY | Feb 24, 1984 | Substantially Equivalent |
| K840287 | BRACHIAL PLEXUS ANESTHESIA TRAY | Feb 23, 1984 | Substantially Equivalent |