FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP
K Number: K053282
·
Decision Dec 13, 2005
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
19
Review Days
18
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Basic Information
- Device Name
- ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP
- K Number
- K053282
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pajunk GmbH
- Date Received
- November 25, 2005
- Decision Date
- December 13, 2005
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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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 |
| 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 |
| K023218 | MODIFICATION TO PLEXOLONG SETS | Mar 24, 2003 | Substantially Equivalent |