K183015 is an FDA 510(k) clearance for the PuraSinus. This device is classified as a Polymer, Ear, Nose And Throat, Synthetic, Absorbable (Class II - Special Controls, product code NHB).
Submitted by 3-D Matrix, Inc. (Needham, US). The FDA issued a Cleared decision on April 12, 2019, 163 days after receiving the submission on October 31, 2018.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620. Ear, Nose, And Throat Absorbable Synthetic Polymer Material Is A Device Material That Is Intended To Be Implanted For Use As A Space-occupying Substance In The Reconstructive Surgery Of The Head And Neck. The Device Is Shaped And Formed By The Surgeon To Conform To The Patient's Needs. This Generic Type Of Device Is Made Of Absorbable Synthetic Polymer Materials..
| 510(k) Number | K183015 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2018 |
| Decision Date | April 12, 2019 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | NHB - Polymer, Ear, Nose And Throat, Synthetic, Absorbable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3620 |
| Definition | Ear, Nose, And Throat Absorbable Synthetic Polymer Material Is A Device Material That Is Intended To Be Implanted For Use As A Space-occupying Substance In The Reconstructive Surgery Of The Head And Neck. The Device Is Shaped And Formed By The Surgeon To Conform To The Patient's Needs. This Generic Type Of Device Is Made Of Absorbable Synthetic Polymer Materials. |