Company ยท US
Pajunk GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2012. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 29, 2012 | K113207 | SONO TAP, TUOHY SONO Pajunk GmbH, DE | BSP |
| Nov 21, 2011 | K113209 | CHIBA SONO Pajunk GmbH, DE | KNW |
| Jun 2, 2006 | K060563 | EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV Pajunk GmbH, DE | CAZ |
| Jan 12, 2006 | K053283 | UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET Pajunk GmbH, DE | CAZ |
| Dec 13, 2005 | K053282 | ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP Pajunk GmbH, DE | GEI |
| Dec 21, 2004 | K043130 | MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS Pajunk GmbH | CAZ |
| Dec 21, 2004 | K042979 | MODIFICATION TO: PLEXALONG SETS Pajunk GmbH | BSP |
| Sep 7, 2004 | K040965 | PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES Pajunk GmbH | BSP |
| May 5, 2004 | K033018 | STIMULONG PLUS CATHETER SET MODEL, VARIOUS Pajunk GmbH | CAZ |
| Mar 5, 2004 | K033249 | PAJUNK MODULAR HANDLE INSTRUMENTS Pajunk GmbH | GCJ |
| Mar 24, 2003 | K023218 | MODIFICATION TO PLEXOLONG SETS Pajunk GmbH | BSP |
| Jun 11, 2002 | K013041 | PLEXOLONG SETS Pajunk GmbH | CAZ |
| Nov 29, 2001 | K011308 | MULTISTIM Pajunk GmbH | BXN |
| Nov 14, 2001 | K012771 | TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX Pajunk GmbH, DE | GCJ |
| Jul 10, 2001 | K011997 | MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX Pajunk GmbH, DE | GCJ |
| Mar 31, 2000 | K000722 | UNIPOLAR NEEDLES Pajunk GmbH | BSP |
| Jul 24, 1992 | K911221 | ATRAUMATIC SPECIAL SPROTTE NEEDLE Pajunk GmbH | BSP |
| May 4, 1992 | K911202 | ATRAUMATIC STANDARD SPROTTE NEEDLE Pajunk GmbH | BSP |
| Oct 21, 1991 | K911260 | ATRAUMATIC STANDARD SPROTTE NEEDLE Pajunk GmbH | BSP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 30, 2019 | Pajunk GmbH SPROTTE Lumbar with Introducer, labeled as the following:
1. Sprotte 22G x 90mm w/ introducer and wings (25/box);
2. Sprotte 22G x 120mm w/ introducer and wings (25/box);
3. Sprotte 19G x 90m Open, Classified |
BSP | K911260 |