The following data is part of a premarket notification filed by Acuvu Inc. with the FDA for Htx Disposable Hysteroscope System.
| Device ID | K211227 |
| 510k Number | K211227 |
| Device Name: | HTx Disposable Hysteroscope System |
| Classification | Hysteroscope (and Accessories) |
| Applicant | AcuVu Inc. 4546 El Camino Real #211 Los Altos, CA 94022 |
| Contact | Sam Mostafavi |
| Correspondent | Sam Mostafavi AcuVu Inc. 4546 El Camino Real #211 Los Altos, CA 94022 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-23 |
| Decision Date | 2021-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974880990031 | K211227 | 000 |
| 26974880990028 | K211227 | 000 |
| 06974880990017 | K211227 | 000 |
| 26974880990042 | K211227 | 000 |