The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4.
| Device ID | K092278 |
| 510k Number | K092278 |
| Device Name: | GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 |
| Classification | Hysteroscope (and Accessories) |
| Applicant | GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Graham A.l. Baillie |
| Correspondent | Graham A.l. Baillie GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-28 |
| Decision Date | 2009-09-29 |
| Summary: | summary |