The following data is part of a premarket notification filed by Iogyn, Inc. with the FDA for Iogyn Endoscope.
| Device ID | K123330 |
| 510k Number | K123330 |
| Device Name: | IOGYN ENDOSCOPE |
| Classification | Hysteroscope (and Accessories) |
| Applicant | IOGYN, INC. 5353 WAYZATA BOULEVARD STE. 505 Minneapolis, MN 55416 |
| Contact | Mary J Edwards |
| Correspondent | Mary J Edwards IOGYN, INC. 5353 WAYZATA BOULEVARD STE. 505 Minneapolis, MN 55416 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-26 |
| Decision Date | 2013-03-19 |
| Summary: | summary |