The following data is part of a premarket notification filed by Acell, Inc. with the FDA for Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal.
| Device ID | K182259 |
| 510k Number | K182259 |
| Device Name: | Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal |
| Classification | Mesh, Surgical |
| Applicant | ACell, Inc. 6640 Eli Whitney Drive Suite 200 Columbia, MD 21046 |
| Contact | Andrea Artman |
| Correspondent | Andrea Artman ACell, Inc. 6640 Eli Whitney Drive Suite 200 Columbia, MD 21046 |
| Product Code | FTM |
| Subsequent Product Code | OWV |
| Subsequent Product Code | OXH |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-21 |
| Decision Date | 2019-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386190001967 | K182259 | 000 |
| 00386190001844 | K182259 | 000 |
| 00386190001851 | K182259 | 000 |
| 00386190001868 | K182259 | 000 |
| 00386190001875 | K182259 | 000 |
| 00386190001882 | K182259 | 000 |
| 00386190001899 | K182259 | 000 |
| 00386190001905 | K182259 | 000 |
| 00386190001912 | K182259 | 000 |
| 00386190001929 | K182259 | 000 |
| 00386190001936 | K182259 | 000 |
| 00386190001943 | K182259 | 000 |
| 00386190001950 | K182259 | 000 |
| 00386190001592 | K182259 | 000 |