The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Omni Hysteroscope, Omni Lok Cervical Seal.
| Device ID | K191281 |
| 510k Number | K191281 |
| Device Name: | Omni Hysteroscope, Omni Lok Cervical Seal |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-13 |
| Decision Date | 2019-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045512191 | K191281 | 000 |
| 25420045513560 | K191281 | 000 |
| 15420045513662 | K191281 | 000 |
| 15420045513655 | K191281 | 000 |
| 15420045513648 | K191281 | 000 |
| 15420045513631 | K191281 | 000 |
| 15420045513624 | K191281 | 000 |
| 15420045513563 | K191281 | 000 |