The following data is part of a premarket notification filed by Inmed Corp. with the FDA for Ureteroscopy Catheter.
| Device ID | K850335 |
| 510k Number | K850335 |
| Device Name: | URETEROSCOPY CATHETER |
| Classification | Catheter, Urological |
| Applicant | INMED CORP. 3030-B HOLCOMB BRIDGE RD. Norcross, GA 30071 |
| Contact | Flo Becker |
| Correspondent | Flo Becker INMED CORP. 3030-B HOLCOMB BRIDGE RD. Norcross, GA 30071 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-28 |
| Decision Date | 1985-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 34026704663416 | K850335 | 000 |
| 44026704542763 | K850335 | 000 |
| 44026704542770 | K850335 | 000 |
| 44026704542787 | K850335 | 000 |
| 24026704542790 | K850335 | 000 |
| 24026704542806 | K850335 | 000 |
| 44026704542817 | K850335 | 000 |
| 34026704663287 | K850335 | 000 |
| 24026704542646 | K850335 | 000 |
| 24026704542752 | K850335 | 000 |
| 24026704542738 | K850335 | 000 |
| 24026704542622 | K850335 | 000 |
| 24026704542639 | K850335 | 000 |
| 24026704542660 | K850335 | 000 |
| 24026704542684 | K850335 | 000 |
| 44026704542695 | K850335 | 000 |
| 44026704542701 | K850335 | 000 |
| 44026704542718 | K850335 | 000 |
| 24026704542721 | K850335 | 000 |
| 44026704542657 | K850335 | 000 |
| 44026704542671 | K850335 | 000 |
| 24026704663334 | K850335 | 000 |
| 24026704663341 | K850335 | 000 |
| 24026704663358 | K850335 | 000 |
| 34026704663362 | K850335 | 000 |
| 24026704663372 | K850335 | 000 |
| 34026704663386 | K850335 | 000 |
| 24026704663396 | K850335 | 000 |
| 34026704663409 | K850335 | 000 |
| 34026704663324 | K850335 | 000 |
| 24026704663310 | K850335 | 000 |
| 24026704663228 | K850335 | 000 |
| 34026704663232 | K850335 | 000 |
| 34026704663249 | K850335 | 000 |
| 24026704663259 | K850335 | 000 |
| 34026704663263 | K850335 | 000 |
| 24026704663273 | K850335 | 000 |
| 34026704663294 | K850335 | 000 |
| 34026704663300 | K850335 | 000 |
| 44026704542541 | K850335 | 000 |