Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- FCDBarium Enema Kit1Product Code
- ITZAssembly, Tube Housing, X-Ray, Therapeutic2Product Code
- IWASource, Wire, Iridium, Radioactive2Product Code
- IWBSystem, Radiation Therapy, Radionuclide2Product Code
- IWDDevice, Beam Limiting, Teletherapy, Radionuclide2Product Code
- IWEMonitor, Patient Position, Light-Beam1Product Code
- IWFNeedle, Isotope, Gold, Titanium, Platinum2Product Code
- IWGSeed, Isotope, Gold, Titanium, Platinum2Product Code
- IWHSource, Teletherapy, Radionuclide1Product Code
- IWISource, Isotope, Sealed, Gold, Titanium, Platinum2Product Code
- IWJSystem, Applicator, Radionuclide, Manual1Product Code
- K010166IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM1Cleared 510(K)
- K980997PGK DEVICE (MODIFIED)1Cleared 510(K)
- K972554REGANES RADIONUCLIDE SEED MAGAZINE1Cleared 510(K)
- K973037N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-10001Cleared 510(K)
- K974118WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET1Cleared 510(K)
- K973786NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE1Cleared 510(K)
- K973638N.I.T., INC. NEEDLE GUIDING TEMPLATE1Cleared 510(K)
- K973184PROSTATE SEEDING NEEDLE1Cleared 510(K)
- K963743MANAN PROSTATE UNI-LOCK1Cleared 510(K)
- K951052WEEKS APPLICATOR1Cleared 510(K)
- K961377MANAN PROSTATE LOCKING INTRODUCER SET1Cleared 510(K)
- K944522MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT1Cleared 510(K)
- K940121IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS1Cleared 510(K)
- K933410IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES1Cleared 510(K)
- K940550COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH1Cleared 510(K)
- K924290BEST INDUSTRIES CARTRIDGE & GUN1Cleared 510(K)
- K913293QUICK SEEDER1Cleared 510(K)
- K921886NEEDLE TECHNOLOGIES SEED IMPLANT NEEDLE1Cleared 510(K)
- K921961SDMO APPLICATOR CODE: ASN.82361Cleared 510(K)
- K910862VARIOUS TEMPLATE APPLICATORS1Cleared 510(K)
- K904933VARIOUS AFTERLOADING APPLICATORS1Cleared 510(K)
- K903403CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR1Cleared 510(K)
- K901842PLASTIC-GUIDES1Cleared 510(K)
- K893703AFTER LOADING DEVICE KIT1Cleared 510(K)
- K891377HILARIS-NORI CERVIX APPLICATOR1Cleared 510(K)
- K890485WANG FRONT LOADING APPLICATOR1Cleared 510(K)
- K890341MICK 200-TP AND MICK TP NEEDLE1Cleared 510(K)
- K890191HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN1Cleared 510(K)
- K871216HILARIS-NORI ENDOMETRIAL APPLICATOR1Cleared 510(K)
- K871213KUMAR CERVICAL APPLICATOR1Cleared 510(K)
- K871217HENSCHKE AFTERLOADING APPLICATOR1Cleared 510(K)
- K850571I-125 IMPLANT GUN1Cleared 510(K)
- K832738HEYER-SCHULTE AFTERLOADING CATHETER1Cleared 510(K)
- K813230AFTERLOADING GYNECOLOGICAL APPLICATOR1Cleared 510(K)
- K801983SCOTT NEEDLE & SCOTT MICK IMPLANTER1Cleared 510(K)
- K800320CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA.1Cleared 510(K)
- IWKCyclotron, Medical2Product Code
- IWLSystem, Radiation Therapy, Neutron, Medical2Product Code
- IWMSynchrotron, Medical2Product Code
- IXIBlock, Beam-Shaping, Radiation Therapy2Product Code
- IYCGenerator, Orthovoltage, Therapeutic X-Ray2Product Code
- IYDGenerator, Low Voltage, Therapeutic X-Ray2Product Code
- IYEAccelerator, Linear, Medical2Product Code
- IYGBetatron, Medical2Product Code
- IYHGenerator, Dermatological (Grenz Ray), Therapeutic X-Ray2Product Code
- IYICollimator, Orthovoltage, Therapeutic X-Ray2Product Code
- IYJCollimator, Low Voltage, Therapeutic X-Ray2Product Code
- IYKCollimator, High Voltage, Therapeutic X-Ray2Product Code
- IYLCollimator, Dermatological, Therapeutic X-Ray2Product Code
- JADSystem, Therapeutic, X-Ray2Product Code
- JAEMicrotron, Medical2Product Code
- JAICouch, Radiation Therapy, Powered2Product Code
- JAQSystem, Applicator, Radionuclide, Remote-Controlled2Product Code
- KPQSystem, Simulation, Radiation Therapy2Product Code
- KPZGenerator, High Voltage, X-Ray, Therapeutic2Product Code
- KQADevice, Beam Limiting, X-Ray, Therapeutic2Product Code
- KXKSource, Brachytherapy, Radionuclide2Product Code
- LHNSystem, Radiation Therapy, Charged-Particle, Medical2Product Code
- MUJSystem, Planning, Radiation Therapy Treatment2Product Code
- MWWAccessory - Film Dosimetry System2Product Code
- NMPNeedle, Isotope, Reprocessed2Product Code
- NZTDosimeter, Ionizing Radiation, Implanted2Product Code
- OINProstate Seeding Kit2Product Code
- ONLConformal Brachytherapy Source2Product Code
- OVBHydrogel Spacer2Product Code
- PCTProstate Immobilizer Rectal Balloon2Product Code
- RGCX-Ray Field Indicator Light (Laser)1Product Code
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K903403
- 510(k) Type
- Traditional
- Applicant
- UNIVERSITY OF MICHIGAN
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/1/1990
- Days to Decision
- 62 days