Dilator, Rectal
FDA product code FFP · Class I (low risk) · 21 CFR 876.5450 · Gastroenterology, Urology
5510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K964634 | AnokryoFFP · Traditional | Mk Conquest Intl., Inc. | 06/06/1997SE |
| K901426 | Colonic Balloon DilatorFFP · Traditional | Telemed Systems, Inc. | 06/21/1990SE |
| K894618 | Inamed Rhemo-D (TM) DilatorFFP · Traditional | Inamed Development Co. | 01/18/1990SE |
| K884713 | Colonic Balloon DialatorsFFP · Traditional | Primrose Medical, Inc. | 09/29/1989SE |
| K830354 | Colorectal DilatorFFP · Traditional | Cleveland Medical Supply & Services | 05/27/1983SE |