Atlas FDA

IWJ

36 FDA 510(k) clearances · Product code

88 daysmedian time to decision
354 days90th percentile
36clearances measured

FDA profile

Official device name
System, Applicator, Radionuclide, Manual
Device class
Class I (low risk)
Regulation
21 CFR 892.5650
Medical specialty
Radiology
Adverse events (MAUDE)
2006: 7 · 2008: 3 · 2009: 3 · 2013: 7 · 2021: 15 · 2025: 40
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM (K010166)Imagyn Medical Technologies, Inc.2001-12-03
PGK DEVICE (MODIFIED) (K980997)Pgk, Inc.1998-09-28
REGANES RADIONUCLIDE SEED MAGAZINE (K972554)Avid N.I.T., Inc.1998-02-17
N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000 (K973037)Avid N.I.T., Inc.1998-01-27
WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET (K974118)Worldwide Medical Technologies, LLC1998-01-23
NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE (K973786)Nw Radiation Therapy Products1998-01-02
N.I.T., INC. NEEDLE GUIDING TEMPLATE (K973638)Avid N.I.T., Inc.1997-12-23
PROSTATE SEEDING NEEDLE (K973184)Promex, Inc.1997-11-21
MANAN PROSTATE UNI-LOCK (K963743)Manan Medical Products, Inc.1996-12-06
WEEKS APPLICATOR (K951052)Duke University Medical Center1996-08-22
MANAN PROSTATE LOCKING INTRODUCER SET (K961377)Manan Medical Products, Inc.1996-07-03
MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT (K944522)Medical Device Technologies, Inc.1995-02-24
IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES (K933410)Best Industries1994-12-30
IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS (K940121)Best Industries1994-12-30
COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH (K940550)Cook, Inc.1994-08-17
BEST INDUSTRIES CARTRIDGE & GUN (K924290)Best Industries1993-06-04
QUICK SEEDER (K913293)Mick Radio-Nuclear Instruments, Inc.1992-10-13
NEEDLE TECHNOLOGIES SEED IMPLANT NEEDLE (K921886)Needle Technologies, Inc.1992-10-05
SDMO APPLICATOR CODE: ASN.8236 (K921961)Medi-Physics Inc. Dba Nycomed Amersham Imaging1992-07-01
VARIOUS TEMPLATE APPLICATORS (K910862)Best Industries1991-04-18
VARIOUS AFTERLOADING APPLICATORS (K904933)Best Assoc. Corp.1991-01-04
CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR (K903403)University of Michigan1990-10-01
PLASTIC-GUIDES (K901842)M & K Co.1990-07-11
AFTER LOADING DEVICE KIT (K893703)Medical Radiation Devices, Inc.1989-09-18
WANG FRONT LOADING APPLICATOR (K890485)Mick Radio-Nuclear Instruments, Inc.1989-04-14
HILARIS-NORI CERVIX APPLICATOR (K891377)Mick Radio-Nuclear Instruments, Inc.1989-04-14
MICK 200-TP AND MICK TP NEEDLE (K890341)Mick Radio-Nuclear Instruments, Inc.1989-03-14
HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN (K890191)Amersham Corp.1989-02-06
HILARIS-NORI ENDOMETRIAL APPLICATOR (K871216)Mick Radio-Nuclear Instruments, Inc.1987-07-21
HENSCHKE AFTERLOADING APPLICATOR (K871217)Mick Radio-Nuclear Instruments, Inc.1987-07-16
KUMAR CERVICAL APPLICATOR (K871213)Mick Radio-Nuclear Instruments, Inc.1987-07-16
I-125 IMPLANT GUN (K850571)Mick Radio-Nuclear Instruments, Inc.1985-03-26
HEYER-SCHULTE AFTERLOADING CATHETER (K832738)American Heyer Schulte1983-09-29
AFTERLOADING GYNECOLOGICAL APPLICATOR (K813230)Esi1981-12-29
SCOTT NEEDLE & SCOTT MICK IMPLANTER (K801983)Mick Radio-Nuclear Instruments, Inc.1980-10-23
CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA. (K800320)Amersham Corp.1980-03-25

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Every clearance here is in the API, with alerts when new ones post.