The following data is part of a premarket notification filed by Endosee Corp with the FDA for Endosee Model 8000 U-scope.
| Device ID | K123151 |
| 510k Number | K123151 |
| Device Name: | ENDOSEE MODEL 8000 U-SCOPE |
| Classification | Hysteroscope (and Accessories) |
| Applicant | ENDOSEE CORP 4546 EL CAMINO REAL, SUITE 215 Los Altos, CA 94022 |
| Contact | Xiaolong(bruce) Ouyang |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-10-09 |
| Decision Date | 2013-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937013320 | K123151 | 000 |
| 00888937013177 | K123151 | 000 |