FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTISTIM
K Number: K011308
·
Decision Nov 29, 2001
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
62
Applicant Total
19
Review Days
213
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MULTISTIM
- K Number
- K011308
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2775
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pajunk GmbH
- Date Received
- April 30, 2001
- Decision Date
- November 29, 2001
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BXN), ordered by most recent decision date.
STIMPOD NMS450 Nerve Stimulator
FDA 510(k)
FDA Class 2
·Anesthesiology
MultiStim ECO
FDA 510(k)
FDA Class 2
·Anesthesiology
SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator
FDA 510(k)
FDA Class 2
·Anesthesiology
MiniStim MS-IVB Peripheral Nerve Stimulator
FDA 510(k)
FDA Class 2
·Anesthesiology
STIMPOD ST2-3010 NERVE STIMULATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Pajunk GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K113207 | SONO TAP, TUOHY SONO | Feb 29, 2012 | Substantially Equivalent |
| K113209 | CHIBA SONO | Nov 21, 2011 | Substantially Equivalent |
| K060563 | EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV | Jun 2, 2006 | Substantially Equivalent |
| K053283 | UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET | Jan 12, 2006 | Substantially Equivalent |
| K053282 | ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP | Dec 13, 2005 | Substantially Equivalent |
| K043130 | MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS | Dec 21, 2004 | Substantially Equivalent |
| K042979 | MODIFICATION TO: PLEXALONG SETS | Dec 21, 2004 | Substantially Equivalent |
| K040965 | PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES | Sep 7, 2004 | Substantially Equivalent |
| K033018 | STIMULONG PLUS CATHETER SET MODEL, VARIOUS | May 5, 2004 | Substantially Equivalent |
| K033249 | PAJUNK MODULAR HANDLE INSTRUMENTS | Mar 5, 2004 | Substantially Equivalent |