Pajunk GmbH
FDA Regulatory Profile
Pajunk GmbH appears in FDA public data with 1 recall, 19 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0234-2020, Class II) was initiated on August 30, 2019. Its most recent 510(k) clearance was granted on February 29, 2012.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 19
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0234-2020 | Class II | SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer a | August 30, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K113207 | SONO TAP, TUOHY SONO | February 29, 2012 |
| K113209 | CHIBA SONO | November 21, 2011 |
| K060563 | EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV | June 2, 2006 |
| K053283 | UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET | January 12, 2006 |
| K053282 | ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP | December 13, 2005 |
| K042979 | MODIFICATION TO: PLEXALONG SETS | December 21, 2004 |
| K043130 | MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS | December 21, 2004 |
| K040965 | PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES | September 7, 2004 |
| K033018 | STIMULONG PLUS CATHETER SET MODEL, VARIOUS | May 5, 2004 |
| K033249 | PAJUNK MODULAR HANDLE INSTRUMENTS | March 5, 2004 |
| K023218 | MODIFICATION TO PLEXOLONG SETS | March 24, 2003 |
| K013041 | PLEXOLONG SETS | June 11, 2002 |
| K011308 | MULTISTIM | November 29, 2001 |
| K012771 | TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX | November 14, 2001 |
| K011997 | MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX | July 10, 2001 |
| K000722 | UNIPOLAR NEEDLES | March 31, 2000 |
| K911221 | ATRAUMATIC SPECIAL SPROTTE NEEDLE | July 24, 1992 |
| K911202 | ATRAUMATIC STANDARD SPROTTE NEEDLE | May 4, 1992 |
| K911260 | ATRAUMATIC STANDARD SPROTTE NEEDLE | October 21, 1991 |