Pajunk GmbH

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
19
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0234-2020Class IISPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer aAugust 30, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K113207SONO TAP, TUOHY SONOFebruary 29, 2012
K113209CHIBA SONONovember 21, 2011
K060563EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IVJune 2, 2006
K053283UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SETJanuary 12, 2006
K053282ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIPDecember 13, 2005
K043130MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETSDecember 21, 2004
K042979MODIFICATION TO: PLEXALONG SETSDecember 21, 2004
K040965PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLESSeptember 7, 2004
K033018STIMULONG PLUS CATHETER SET MODEL, VARIOUSMay 5, 2004
K033249PAJUNK MODULAR HANDLE INSTRUMENTSMarch 5, 2004
K023218MODIFICATION TO PLEXOLONG SETSMarch 24, 2003
K013041PLEXOLONG SETSJune 11, 2002
K011308MULTISTIMNovember 29, 2001
K012771TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XXNovember 14, 2001
K011997MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XXJuly 10, 2001
K000722UNIPOLAR NEEDLESMarch 31, 2000
K911221ATRAUMATIC SPECIAL SPROTTE NEEDLEJuly 24, 1992
K911202ATRAUMATIC STANDARD SPROTTE NEEDLEMay 4, 1992
K911260ATRAUMATIC STANDARD SPROTTE NEEDLEOctober 21, 1991