K120831 is an FDA 510(k) clearance for the ANCHORSURE, a Fixation, Non-absorbable Or Absorbable, For Pelvic Use (Class II — Special Controls, product code PBQ), submitted by Neomedic International S.L. (Minneapolis, US). The FDA issued a Cleared decision on October 12, 2012, 207 days after receiving the submission on March 19, 2012. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K120831 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 19, 2012 |
| Decision Date | October 12, 2012 |
| Days to Decision | 207 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | PBQ — Fixation, Non-absorbable Or Absorbable, For Pelvic Use |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |
| Definition | Attaching Suture Or Stapling Ligaments Of The Pelvic Floor. |