Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- LWHCounter, Sponge, Surgical1Product Code
- K121274PIXEL APP1Cleared 510(K)
- K120473PIXEL APP1Cleared 510(K)
- K100551ORLOCATE SYSTEM MODEL ORL 1001Cleared 510(K)
- K093557SMARTWAND-DTX1Cleared 510(K)
- K073180SMARTSPONGE PLUS SYSTEM1Cleared 510(K)
- K071355SMARTSPONGE SYSTEM1Cleared 510(K)
- K062642RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A1Cleared 510(K)
- K061316MEDLINE SURGICAL SPONGE SCANNER1Cleared 510(K)
- K060076SURGICOUNT SAFETY-SPONGE SYSTEM1Cleared 510(K)
- K982260MARKWELL GAUZE SPONGE1Cleared 510(K)
Show All 15 Submissions
- PBZImage Processing Device For Estimation Of External Blood Loss2Product Code
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
PIXEL APP
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K120473
- 510(k) Type
- Traditional
- Applicant
- GAUSS SURGICAL, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/9/2012
- Days to Decision
- 53 days
- Submission Type
- Summary