FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IR-192 IMPLANT, MODIFICATION
K Number: K915253
·
Decision Feb 27, 1992
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
7
Applicant Total
7
Review Days
101
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Basic Information
- Device Name
- IR-192 IMPLANT, MODIFICATION
- K Number
- K915253
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Omnitron Intl., Inc.
- Date Received
- November 18, 1991
- Decision Date
- February 27, 1992
- Product Code
- IWA
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IWA | Source, Wire, Iridium, Radioactive | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IWA), ordered by most recent decision date.
CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD
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IR-192 IMPLANT
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IRIDIUM SEEDS
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IR-192 IMPLANT
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IRIDIUM 192 WIRES
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WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD
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·Radiology
Other Clearances by Omnitron Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K901615 | PULMOCATH INTRABRONCHIAL CATHETER | Nov 27, 1992 | Substantially Equivalent |
| K923130 | IR-192 IMPLANT -- MODIFICATION | Sep 21, 1992 | Substantially Equivalent |
| K920431 | OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE | May 29, 1992 | Substantially Equivalent |
| K913908 | OMNITRON GYN APPLICATOR SYSTEM | Mar 6, 1992 | Substantially Equivalent |
| K911775 | OMNICATH IMPLANTED CATHETER AND DEPOT | May 8, 1991 | Substantially Equivalent |
| K881665 | OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR | Aug 11, 1988 | Substantially Equivalent |