FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Triton System
K Number: K160338
·
Decision Aug 5, 2016
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
5
Applicant Total
6
Review Days
179
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Basic Information
- Device Name
- Triton System
- K Number
- K160338
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2750
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gauss Surgical, Inc.,
- Date Received
- February 8, 2016
- Decision Date
- August 5, 2016
- Product Code
- PBZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PBZ | Image Processing Device For Estimation Of External Blood Loss | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PBZ), ordered by most recent decision date.
SurgiCount+ System
FDA 510(k)
FDA Class 2
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SurgiCount+ System
FDA 510(k)
FDA Class 2
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Triton Sponge System
FDA 510(k)
FDA Class 2
·General Hospital
Triton Canister System
FDA 510(k)
FDA Class 2
·General Hospital
PIXEL 3 SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Gauss Surgical, Inc.,
| K Number | Device Name | ||
|---|---|---|---|
| K163507 | Triton Sponge System | Apr 25, 2017 | Substantially Equivalent |
| K142801 | Triton Canister System | Mar 12, 2015 | Substantially Equivalent |
| DEN130015 | PIXEL 3 SYSTEM | May 9, 2014 | Unknown |
| K121274 | PIXEL APP | Jun 27, 2012 | Substantially Equivalent |
| K120473 | PIXEL APP | Apr 9, 2012 | Substantially Equivalent |