K220420 is an FDA 510(k) clearance for the Saffron Fixation System. This device is classified as a Fixation, Non-absorbable Or Absorbable, For Pelvic Use (Class II - Special Controls, product code PBQ).
Submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on June 10, 2022, 116 days after receiving the submission on February 14, 2022.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530. Attaching Suture Or Stapling Ligaments Of The Pelvic Floor..
| 510(k) Number | K220420 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2022 |
| Decision Date | June 10, 2022 |
| Days to Decision | 116 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. |