The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Stratafix Symmetric Pds Plus Knotless Tissue Control Devices.
| Device ID | K141776 |
| 510k Number | K141776 |
| Device Name: | STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | ETHICON, INC. ROUTE 22 WEST Somerville, NJ 08876 -0151 |
| Contact | Peter Cecchini |
| Correspondent | Peter Cecchini ETHICON, INC. ROUTE 22 WEST Somerville, NJ 08876 -0151 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2014-07-02 |
| Decision Date | 2014-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705031237753 | K141776 | 000 |
| 30705031237746 | K141776 | 000 |
| 30705031237739 | K141776 | 000 |
| 30705031237715 | K141776 | 000 |
| 30705031237708 | K141776 | 000 |