Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| (unnamed) | Steen HS Catheter, 7F | C R I | LKF | 00852073002890 |
| (unnamed) | Stylet | C R I | LKF | 00852073002098 |
| HSG Kits | HSG tray with 5F HS | MedGyn Products, Inc. | LKF | M803TMI1160 |
| HSG Kits | HSG tray | MedGyn Products, Inc. | LKF | M803TMI1157 |
| HSG Kits | HSG tray with Shapeable 7F HS | MedGyn Products, Inc. | LKF | M803TMI1199 |
| (unnamed) | 5F Shapeable HS Catheter | C R I | LKF | 00852073002067 |
| (unnamed) | HSG Tray | C R I | LKF | 00852073002999 |
| HS Catheters | Miller advance catheter,28cm | MedGyn Products, Inc. | LKF | M803TMI20002 |
| (unnamed) | 5F HS Catheter | C R I | LKF | 00852073002043 |
| (unnamed) | 5F HS Catheter | C R I | LKF | 00852073002548 |
| HS catheters | Shapeable HS Catheter, 5F | MedGyn Products, Inc. | LKF | M803TMI1185 |
| (unnamed) | Two-Tap HS Catheter, 5F | C R I | LKF | 00852073002814 |
| HS Catheters | Shapeable HS Catheter,7F | MedGyn Products, Inc. | LKF | M803TMI1187 |
| (unnamed) | Stylet | C R I | LKF | 00852073002562 |
| HS Catheters | Steen, open-tip HS Catheter | MedGyn Products, Inc. | LKF | M803TMI1188 |
| (unnamed) | 7F HS Catheter | C R I | LKF | 00852073002050 |
| (unnamed) | Two-Tap Shapeable HS Catheter, 7F | C R I | LKF | 00852073002845 |
| (unnamed) | HSG Tray | C R I | LKF | 00852073002579 |
| HS Catheters | HS Catheter,5F | MedGyn Products, Inc. | LKF | M803TMI1154 |
| HSG Kits | HSG tray with 7F HS | MedGyn Products, Inc. | LKF | M803TMI1161 |
| (unnamed) | Steen HS Catheter, 5F | C R I | LKF | 00852073002883 |
| Batrik H/S Catheter TM 7F | 51-5007 | Batrik Medical Manufacturing Inc | LKF | 00690521013742 |
| (unnamed) | HSG Tray | C R I | LKF | 00852073002609 |
| (unnamed) | HS Catheter w/Depth Marks, 7F | C R I | LKF | 00852073002357 |
| HS Catheters | HS Catheter,7F | MedGyn Products, Inc. | LKF | M803TMI1155 |