FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PIXEL APP
K Number: K121274
·
Decision Jun 27, 2012
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
14
Applicant Total
6
Review Days
61
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Basic Information
- Device Name
- PIXEL APP
- K Number
- K121274
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 880.2740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gauss Surgical, Inc.,
- Date Received
- April 27, 2012
- Decision Date
- June 27, 2012
- Product Code
- LWH
- 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 |
|---|---|---|---|
| LWH | Counter, Sponge, Surgical | FDA class 1 | 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 |
| DEN130015 | PIXEL 3 SYSTEM | May 9, 2014 | Unknown |
| K120473 | PIXEL APP | Apr 9, 2012 | Substantially Equivalent |