FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
Rectal Applicator
K Number: K251037
·
Decision Dec 19, 2025
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
206
Applicant Total
11
Review Days
260
Basic Information
- Device Name
- Rectal Applicator
- K Number
- K251037
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nucletron B.V.
- Date Received
- April 3, 2025
- Decision Date
- December 19, 2025
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAQ), ordered by most recent decision date.
MAASTRO Rectal Applicator Set
FDA 510(k)
FDA Class 2
·Radiology
Guided Aarhus Applicator Set
FDA 510(k)
FDA Class 2
·Radiology
CT/ MR Tandem and Ovoid Set
FDA 510(k)
FDA Class 2
·Radiology
Intracavitary/Interstitial System
FDA 510(k)
FDA Class 2
·Radiology
Titanium Flexible Geometry FSD Applicator Set (GM11013400)
FDA 510(k)
FDA Class 2
·Radiology
Mould Probe MR Safe
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Nucletron B.V.
| K Number | Device Name | ||
|---|---|---|---|
| K213942 | Esteya | Jan 11, 2022 | Substantially Equivalent |
| K201272 | Geneva | Jul 16, 2020 | Substantially Equivalent |
| K161688 | Advanced Gynecological Applicator | Jan 27, 2017 | Substantially Equivalent |
| K151272 | Henschke Titanium Applicator Set | Jun 23, 2015 | Substantially Equivalent |
| K142439 | Martinez Prostate Template Set | Mar 10, 2015 | Substantially Equivalent |
| K140803 | LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM | Jun 26, 2014 | Substantially Equivalent |
| K132816 | ONCENTRA BRACHY | Jun 13, 2014 | Substantially Equivalent |
| K132889 | FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM) | Feb 26, 2014 | Substantially Equivalent |
| K132874 | LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM | Feb 21, 2014 | Substantially Equivalent |
| K132092 | ESTEYA | Sep 26, 2013 | Substantially Equivalent |