IWJ · System, Applicator, Radionuclide, Manual
Radiology · 21 CFR 892.5650 · Class 1
Overview
| Product Code | IWJ |
|---|---|
| Device Name | System, Applicator, Radionuclide, Manual |
| Regulation | 21 CFR 892.5650 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A manual radionuclide applicator system is a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
Cleared Devices (36)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K010166 | IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM | Imagyn Medical Technologies, Inc. | Dec 3, 2001 | SESE |
| K980997 | PGK DEVICE (MODIFIED) | Pgk, Inc. | Sep 28, 1998 | SESE |
| K972554 | REGANES RADIONUCLIDE SEED MAGAZINE | Avid N.I.T., Inc. | Feb 17, 1998 | SESE |
| K973037 | N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000 | Avid N.I.T., Inc. | Jan 27, 1998 | SESE |
| K974118 | WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET | Worldwide Medical Technologies, LLC | Jan 23, 1998 | SESE |
| K973786 | NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE | Nw Radiation Therapy Products | Jan 2, 1998 | SESE |
| K973638 | N.I.T., INC. NEEDLE GUIDING TEMPLATE | Avid N.I.T., Inc. | Dec 23, 1997 | SESE |
| K973184 | PROSTATE SEEDING NEEDLE | Promex, Inc. | Nov 21, 1997 | SESE |
| K963743 | MANAN PROSTATE UNI-LOCK | Manan Medical Products, Inc. | Dec 6, 1996 | SESE |
| K951052 | WEEKS APPLICATOR | Duke University Medical Center | Aug 22, 1996 | SESE |
| K961377 | MANAN PROSTATE LOCKING INTRODUCER SET | Manan Medical Products, Inc. | Jul 3, 1996 | SESE |
| K944522 | MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT | Medical Device Technologies, Inc. | Feb 24, 1995 | SESE |
| K940121 | IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS | Best Industries | Dec 30, 1994 | SESE |
| K933410 | IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES | Best Industries | Dec 30, 1994 | SESE |
| K940550 | COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH | Cook, Inc. | Aug 17, 1994 | SESE |
| K924290 | BEST INDUSTRIES CARTRIDGE & GUN | Best Industries | Jun 4, 1993 | SESE |
| K913293 | QUICK SEEDER | Mick Radio-Nuclear Instruments, Inc. | Oct 13, 1992 | SESE |
| K921886 | NEEDLE TECHNOLOGIES SEED IMPLANT NEEDLE | Needle Technologies, Inc. | Oct 5, 1992 | SESE |
| K921961 | SDMO APPLICATOR CODE: ASN.8236 | Medi-Physics Inc. Dba Nycomed Amersham Imaging | Jul 1, 1992 | SESE |
| K910862 | VARIOUS TEMPLATE APPLICATORS | Best Industries | Apr 18, 1991 | SESE |
| K904933 | VARIOUS AFTERLOADING APPLICATORS | Best Assoc. Corp. | Jan 4, 1991 | SESE |
| K903403 | CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR | University of Michigan | Oct 1, 1990 | SESE |
| K901842 | PLASTIC-GUIDES | M & K Co. | Jul 11, 1990 | SESE |
| K893703 | AFTER LOADING DEVICE KIT | Medical Radiation Devices, Inc. | Sep 18, 1989 | SESE |
| K891377 | HILARIS-NORI CERVIX APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | Apr 14, 1989 | SESE |
| K890485 | WANG FRONT LOADING APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | Apr 14, 1989 | SESE |
| K890341 | MICK 200-TP AND MICK TP NEEDLE | Mick Radio-Nuclear Instruments, Inc. | Mar 14, 1989 | SESE |
| K890191 | HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN | Amersham Corp. | Feb 6, 1989 | SESE |
| K871216 | HILARIS-NORI ENDOMETRIAL APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | Jul 21, 1987 | SESE |
| K871217 | HENSCHKE AFTERLOADING APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | Jul 16, 1987 | SESE |
| K871213 | KUMAR CERVICAL APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | Jul 16, 1987 | SESE |
| K850571 | I-125 IMPLANT GUN | Mick Radio-Nuclear Instruments, Inc. | Mar 26, 1985 | SESE |
| K832738 | HEYER-SCHULTE AFTERLOADING CATHETER | American Heyer Schulte | Sep 29, 1983 | SESE |
| K813230 | AFTERLOADING GYNECOLOGICAL APPLICATOR | Esi | Dec 29, 1981 | SESE |
| K801983 | SCOTT NEEDLE & SCOTT MICK IMPLANTER | Mick Radio-Nuclear Instruments, Inc. | Oct 23, 1980 | SESE |
| K800320 | CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA. | Amersham Corp. | Mar 25, 1980 | SESE |
Top Applicants
- Mick Radio-Nuclear Instruments, Inc. — 9 clearances
- Best Industries — 4 clearances
- Avid N.I.T., Inc. — 3 clearances
- Manan Medical Products, Inc. — 2 clearances
- Amersham Corp. — 2 clearances
