FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
PIXEL 3 SYSTEM
K Number: DEN130015
·
Decision May 9, 2014
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
5
Applicant Total
6
Review Days
459
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Basic Information
- Device Name
- PIXEL 3 SYSTEM
- K Number
- DEN130015
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 880.2750
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Applicant
- Gauss Surgical, Inc.,
- Date Received
- February 4, 2013
- Decision Date
- May 9, 2014
- 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 |
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Other Clearances by Gauss Surgical, Inc.,
| K Number | Device Name | ||
|---|---|---|---|
| K163507 | Triton Sponge System | Apr 25, 2017 | Substantially Equivalent |
| K160338 | Triton System | Aug 5, 2016 | Substantially Equivalent |
| K142801 | Triton Canister System | Mar 12, 2015 | Substantially Equivalent |
| K121274 | PIXEL APP | Jun 27, 2012 | Substantially Equivalent |
| K120473 | PIXEL APP | Apr 9, 2012 | Substantially Equivalent |