K181672 is an FDA 510(k) clearance for the SureTouch Mobile Pressure Mapping System. This device is classified as a System, Documentation, Breast Lesion (Class II - Special Controls, product code NKA).
Submitted by Sure, Inc. (Palos Verdes Estates, US). The FDA issued a Cleared decision on June 28, 2019, 368 days after receiving the submission on June 25, 2018.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2990. A Breast Lesion Documentation Device Is A Device For Recording And Documenting Palpable Breast Lesions Detected During A Clinical Breast Exam..
| 510(k) Number | K181672 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2018 |
| Decision Date | June 28, 2019 |
| Days to Decision | 368 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | NKA - System, Documentation, Breast Lesion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2990 |
| Definition | A Breast Lesion Documentation Device Is A Device For Recording And Documenting Palpable Breast Lesions Detected During A Clinical Breast Exam. |