The following data is part of a premarket notification filed by Endo Technic Corp. with the FDA for 1-125 Endoseed.
| Device ID | K914825 |
| 510k Number | K914825 |
| Device Name: | 1-125 ENDOSEED |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | ENDO TECHNIC CORP. 4340 LEAVENWORTH Omaha, NE 68105 |
| Contact | Roger Good |
| Correspondent | Roger Good ENDO TECHNIC CORP. 4340 LEAVENWORTH Omaha, NE 68105 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-28 |
| Decision Date | 1992-03-19 |