The following data is part of a premarket notification filed by Endosec Corporation with the FDA for U-scope 8000 System With Hsc+emb Cannula.
| Device ID | K132384 |
| 510k Number | K132384 |
| Device Name: | U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA |
| Classification | Hysteroscope (and Accessories) |
| Applicant | ENDOSEC CORPORATION 4546 EL CAMINO REAL, STE 215 Los Altos, CA 94022 |
| Contact | Pin Yu |
| Correspondent | Pin Yu ENDOSEC CORPORATION 4546 EL CAMINO REAL, STE 215 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 | 2013-07-31 |
| Decision Date | 2014-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60888937013780 | K132384 | 000 |
| 00888937013795 | K132384 | 000 |