FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STIMULONG PLUS CATHETER SET MODEL, VARIOUS
K Number: K033018
·
Decision May 5, 2004
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
154
Applicant Total
19
Review Days
222
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Basic Information
- Device Name
- STIMULONG PLUS CATHETER SET MODEL, VARIOUS
- K Number
- K033018
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5140
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pajunk GmbH
- Date Received
- September 26, 2003
- Decision Date
- May 5, 2004
- Product Code
- CAZ
- 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 |
|---|---|---|---|
| CAZ | Anesthesia Conduction Kit | FDA class 2 | Anesthesiology |
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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 |
| K033249 | PAJUNK MODULAR HANDLE INSTRUMENTS | Mar 5, 2004 | Substantially Equivalent |
| K023218 | MODIFICATION TO PLEXOLONG SETS | Mar 24, 2003 | Substantially Equivalent |