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IWJ — System, Applicator, Radionuclide, Manual Class I

FDA Device Classification

Classification Details

Product Code
IWJ
Device Class
Class I
Regulation Number
892.5650
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K010166imagyn medical technologiesIMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEMDecember 3, 2001
K980997pgkPGK DEVICE (MODIFIED)September 28, 1998
K972554avid n.i.tREGANES RADIONUCLIDE SEED MAGAZINEFebruary 17, 1998
K973037avid n.i.tN.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000January 27, 1998
K974118worldwide medical technologiesWORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SETJanuary 23, 1998
K973786nw radiation therapy productsNORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDEJanuary 2, 1998
K973638avid n.i.tN.I.T., INC. NEEDLE GUIDING TEMPLATEDecember 23, 1997
K973184promexPROSTATE SEEDING NEEDLENovember 21, 1997
K963743manan medical productsMANAN PROSTATE UNI-LOCKDecember 6, 1996
K951052duke university medical centerWEEKS APPLICATORAugust 22, 1996
K961377manan medical productsMANAN PROSTATE LOCKING INTRODUCER SETJuly 3, 1996
K944522medical device technologiesMORGANSTERN PROSTATE STABILIZATION AND SEEDING KITFebruary 24, 1995
K940121best industriesIMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERSDecember 30, 1994
K933410best industriesIMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RDecember 30, 1994
K940550cookCOOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATHAugust 17, 1994
K924290best industriesBEST INDUSTRIES CARTRIDGE & GUNJune 4, 1993
K913293mick radio-nuclear instrumentsQUICK SEEDEROctober 13, 1992
K921886needle technologiesNEEDLE TECHNOLOGIES SEED IMPLANT NEEDLEOctober 5, 1992
K921961medi-physics inc. dba nycomed amersham imagingSDMO APPLICATOR CODE: ASN.8236July 1, 1992
K910862best industriesVARIOUS TEMPLATE APPLICATORSApril 18, 1991