FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PAJUNK MODULAR HANDLE INSTRUMENTS
K Number: K033249
·
Decision Mar 5, 2004
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
19
Review Days
150
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Basic Information
- Device Name
- PAJUNK MODULAR HANDLE INSTRUMENTS
- K Number
- K033249
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pajunk GmbH
- Date Received
- October 7, 2003
- Decision Date
- March 5, 2004
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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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 |
| K033018 | STIMULONG PLUS CATHETER SET MODEL, VARIOUS | May 5, 2004 | Substantially Equivalent |
| K023218 | MODIFICATION TO PLEXOLONG SETS | Mar 24, 2003 | Substantially Equivalent |