FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001
K Number: K041715
·
Decision Mar 24, 2005
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
206
Applicant Total
27
Review Days
274
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Basic Information
- Device Name
- INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001
- K Number
- K041715
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nucletron Corp.
- Date Received
- June 23, 2004
- Decision Date
- March 24, 2005
- Product Code
- JAQ
- 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 |
|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | FDA class 2 | Radiology |
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Other Clearances by Nucletron Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K092804 | MICROSELECTRON HDR V2, MODEL 105.999 | Oct 8, 2009 | Substantially Equivalent |
| K091598 | LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS | Jun 29, 2009 | Substantially Equivalent |
| K072445 | INTEGRATED BRACHYTHERAPY UNIT - DIGITAL | Sep 14, 2007 | Substantially Equivalent |
| K041933 | MICROSELECTRON PDR | Aug 18, 2004 | Substantially Equivalent |
| K041719 | ONCENTRA-VISIR | Jul 22, 2004 | Substantially Equivalent |
| K031158 | SWIFT 2.0, MODEL 132.001 | Aug 7, 2003 | Substantially Equivalent |
| K031349 | OTP 1.2 | Aug 7, 2003 | Substantially Equivalent |
| K021286 | MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES | May 23, 2002 | Substantially Equivalent |
| K020015 | IMPLANT GUIDANCE SYSTEM APPLICATOR SET | Mar 13, 2002 | Substantially Equivalent |
| K010032 | SEED SELECTRON MODEL V. 1.0 | Oct 17, 2001 | Substantially Equivalent |