Product Code: IWJ FDA class 1 21 CFR 892.5650

System, Applicator, Radionuclide, Manual

Radiology

A manual radionuclide applicator system is a brachytherapy delivery system in which radioactive sources are loaded manually into applicators placed within or near the tumor, used for localized radiation therapy of gynecological cancers and other conditions. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IWJ, regulated under 21 CFR 892.5650, within the Radiology medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: IWJ
Device Class: FDA class 1
Regulation Number: 892.5650
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 36 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K010166	IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM	Dec 03, 2001	Substantially Equivalent	Imagyn Medical Technologies, Inc.
K980997	PGK DEVICE (MODIFIED)	Sep 28, 1998	Substantially Equivalent	Pgk, Inc.
K972554	REGANES RADIONUCLIDE SEED MAGAZINE	Feb 17, 1998	Substantially Equivalent	Avid N.I.T., Inc.
K973037	N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000	Jan 27, 1998	Substantially Equivalent	Avid N.I.T., Inc.
K974118	WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET	Jan 23, 1998	Substantially Equivalent	Worldwide Medical Technologies, LLC
K973786	NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE	Jan 02, 1998	Substantially Equivalent	Nw Radiation Therapy Products
K973638	N.I.T., INC. NEEDLE GUIDING TEMPLATE	Dec 23, 1997	Substantially Equivalent	Avid N.I.T., Inc.
K973184	PROSTATE SEEDING NEEDLE	Nov 21, 1997	Substantially Equivalent	Promex, Inc.
K963743	MANAN PROSTATE UNI-LOCK	Dec 06, 1996	Substantially Equivalent	Manan Medical Products, Inc.
K951052	WEEKS APPLICATOR	Aug 22, 1996	Substantially Equivalent	Duke University Medical Center
K961377	MANAN PROSTATE LOCKING INTRODUCER SET	Jul 03, 1996	Substantially Equivalent	Manan Medical Products, Inc.
K944522	MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT	Feb 24, 1995	Substantially Equivalent	Medical Device Technologies, Inc.
K940121	IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS	Dec 30, 1994	Substantially Equivalent	Best Industries
K933410	IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES	Dec 30, 1994	Substantially Equivalent	Best Industries
K940550	COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH	Aug 17, 1994	Substantially Equivalent	Cook, Inc.
K924290	BEST INDUSTRIES CARTRIDGE & GUN	Jun 04, 1993	Substantially Equivalent	Best Industries
K913293	QUICK SEEDER	Oct 13, 1992	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K921886	NEEDLE TECHNOLOGIES SEED IMPLANT NEEDLE	Oct 05, 1992	Substantially Equivalent	Needle Technologies, Inc.
K921961	SDMO APPLICATOR CODE: ASN.8236	Jul 01, 1992	Substantially Equivalent	Medi-Physics Inc. Dba Nycomed Amersham Imaging
K910862	VARIOUS TEMPLATE APPLICATORS	Apr 18, 1991	Substantially Equivalent	Best Industries
K904933	VARIOUS AFTERLOADING APPLICATORS	Jan 04, 1991	Substantially Equivalent	Best Assoc. Corp.
K903403	CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR	Oct 01, 1990	Substantially Equivalent	University of Michigan
K901842	PLASTIC-GUIDES	Jul 11, 1990	Substantially Equivalent	M & K Co.
K893703	AFTER LOADING DEVICE KIT	Sep 18, 1989	Substantially Equivalent	Medical Radiation Devices, Inc.
K891377	HILARIS-NORI CERVIX APPLICATOR	Apr 14, 1989	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K890485	WANG FRONT LOADING APPLICATOR	Apr 14, 1989	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K890341	MICK 200-TP AND MICK TP NEEDLE	Mar 14, 1989	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K890191	HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN	Feb 06, 1989	Substantially Equivalent	Amersham Corp.
K871216	HILARIS-NORI ENDOMETRIAL APPLICATOR	Jul 21, 1987	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K871217	HENSCHKE AFTERLOADING APPLICATOR	Jul 16, 1987	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K871213	KUMAR CERVICAL APPLICATOR	Jul 16, 1987	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K850571	I-125 IMPLANT GUN	Mar 26, 1985	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K832738	HEYER-SCHULTE AFTERLOADING CATHETER	Sep 29, 1983	Substantially Equivalent	American Heyer Schulte
K813230	AFTERLOADING GYNECOLOGICAL APPLICATOR	Dec 29, 1981	Substantially Equivalent	Esi
K801983	SCOTT NEEDLE & SCOTT MICK IMPLANTER	Oct 23, 1980	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K800320	CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA.	Mar 25, 1980	Substantially Equivalent	Amersham Corp.