The following data is part of a premarket notification filed by Acell, Inc. with the FDA for Gentrix Surgical Matrix.
| Device ID | K162554 |
| 510k Number | K162554 |
| Device Name: | Gentrix Surgical Matrix |
| Classification | Mesh, Surgical |
| Applicant | Acell, Inc. 6640 Eli Whitney Drive Columbia, MD 21046 |
| Contact | Salman Elmi |
| Correspondent | John Smith Hogan Lovells US LLP 555 Thirteenth Street NW Washington, DC 20004 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-13 |
| Decision Date | 2016-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386190001387 | K162554 | 000 |
| 00386190001226 | K162554 | 000 |
| 00386190001233 | K162554 | 000 |
| 00386190001240 | K162554 | 000 |
| 00386190001301 | K162554 | 000 |
| 00386190001318 | K162554 | 000 |
| 00386190001325 | K162554 | 000 |
| 00386190001332 | K162554 | 000 |
| 00386190001349 | K162554 | 000 |
| 00386190001356 | K162554 | 000 |
| 00386190001363 | K162554 | 000 |
| 00386190001370 | K162554 | 000 |
| 00386190001219 | K162554 | 000 |