The following data is part of a premarket notification filed by Hologic, Inc with the FDA for Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths.
| Device ID | K182006 |
| 510k Number | K182006 |
| Device Name: | Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths |
| Classification | Hysteroscope (and Accessories) |
| Applicant | Hologic, Inc 250 Campus Drive Marlborough, MA 01752 |
| Contact | Rachelle D. Fitzgerald |
| Correspondent | Rachelle D. Fitzgerald Hologic, Inc 250 Campus Drive Marlborough, MA 01752 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-27 |
| Decision Date | 2018-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045510357 | K182006 | 000 |
| 15420045510340 | K182006 | 000 |
| 15420045510272 | K182006 | 000 |
| 15420045510289 | K182006 | 000 |
| 15420045510265 | K182006 | 000 |
| 15420045510258 | K182006 | 000 |