510(k) K163507
- Device
- Triton Sponge System
- Applicant
- Gauss Surgical, Inc.
- 510(k) number
- K163507
- Product code
- PBZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-04-25
- Date received
- 2016-12-14
- Regulation
- 880.2750
- Classification name
- Image Processing Device For Estimation Of External Blood Loss
- Medical specialty
- General Hospital
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Artie Kaushik
- Address
- 334 State St., Suite 201 Los Altos CA US 94022 94022
FDA Registration Numbers#
- 3015967359
- 3010141593
Source Documents#
Other 510(k) Records For Product Code PBZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252282 | SurgiCount+ System | Stryker Instruments | 2026-03-16 |
| K232250 | SurgiCount+ System | Stryker Instruments | 2024-01-11 |
| K160338 | Triton System | Gauss Surgical, Inc., | 2016-08-05 |
| K142801 | Triton Canister System | Gauss Surgical, Inc., | 2015-03-12 |
| DEN130015 | PIXEL 3 SYSTEM | Gauss Surgical, Inc., | 2014-05-09 |
Legacy Summary#
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FDA Review#
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