The following data is part of a premarket notification filed by Gauss Surgical, Inc. with the FDA for Triton Sponge System.
| Device ID | K163507 |
| 510k Number | K163507 |
| Device Name: | Triton Sponge System |
| Classification | Image Processing Device For Estimation Of External Blood Loss |
| Applicant | Gauss Surgical, Inc. 334 State St., Suite 201 Los Altos, CA 94022 |
| Contact | Artie Kaushik |
| Correspondent | Artie Kaushik Gauss Surgical, Inc. 334 State St., Suite 201 Los Altos, CA 94022 |
| Product Code | PBZ |
| CFR Regulation Number | 880.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-14 |
| Decision Date | 2017-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859506006098 | K163507 | 000 |
| 00859506006081 | K163507 | 000 |
| 00859506006067 | K163507 | 000 |
| 10859506006095 | K163507 | 000 |