The following data is part of a premarket notification filed by Nucletron Bv with the FDA for Advanced Gynecological Applicator.
| Device ID | K161688 |
| 510k Number | K161688 |
| Device Name: | Advanced Gynecological Applicator |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | NUCLETRON BV WAARDGELDER 1 Veenendaal, NL 3905 Th |
| Contact | Rudolf Vos |
| Correspondent | Rudolf Vos NUCLETRON BV WAARDGELDER 1 Veenendaal, NL 3905 Th |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-20 |
| Decision Date | 2017-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717213054325 | K161688 | 000 |
| 08717213055643 | K161688 | 000 |
| 08717213055629 | K161688 | 000 |
| 08717213055599 | K161688 | 000 |
| 08717213055575 | K161688 | 000 |
| 08717213055551 | K161688 | 000 |
| 08717213055544 | K161688 | 000 |
| 08717213055513 | K161688 | 000 |
| 08717213054844 | K161688 | 000 |
| 08717213055124 | K161688 | 000 |
| 08717213054820 | K161688 | 000 |
| 08717213054868 | K161688 | 000 |
| 08717213054875 | K161688 | 000 |
| 08717213055070 | K161688 | 000 |
| 08717213054851 | K161688 | 000 |
| 08717213055742 | K161688 | 000 |
| 08717213055773 | K161688 | 000 |
| 08717213054318 | K161688 | 000 |
| 08717213054790 | K161688 | 000 |
| 08717213054783 | K161688 | 000 |
| 08717213054776 | K161688 | 000 |
| 08717213055032 | K161688 | 000 |
| 08717213054899 | K161688 | 000 |
| 08717213054882 | K161688 | 000 |
| 08717213054813 | K161688 | 000 |
| 08717213054806 | K161688 | 000 |
| 08717213054752 | K161688 | 000 |
| 08717213054905 | K161688 | 000 |
| 08717213054912 | K161688 | 000 |
| 08717213054929 | K161688 | 000 |
| 08717213055797 | K161688 | 000 |
| 08717213054837 | K161688 | 000 |