The following data is part of a premarket notification filed by Caldera Medical, Inc. with the FDA for Benesta Hysteroscope.
| Device ID | K192822 |
| 510k Number | K192822 |
| Device Name: | Benesta Hysteroscope |
| Classification | Hysteroscope (and Accessories) |
| Applicant | Caldera Medical, Inc. 5171 Clareton Drive Agoura Hills, CA 91301 |
| Contact | Vicki Gail |
| Correspondent | Vicki Gail Caldera Medical, Inc. 5171 Clareton Drive Agoura Hills, CA 91301 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-01 |
| Decision Date | 2020-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857492008041 | K192822 | 000 |