K092590 is an FDA 510(k) clearance for the PDS PLATES. This device is classified as a Polymer, Ear, Nose And Throat, Synthetic, Absorbable (Class II - Special Controls, product code NHB).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on February 17, 2010, 177 days after receiving the submission on August 24, 2009.
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 | K092590 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 2009 |
| Decision Date | February 17, 2010 |
| Days to Decision | 177 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. |