The following data is part of a premarket notification filed by Ethicon, Inc with the FDA for Stratafix Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device.
| Device ID | K192580 |
| 510k Number | K192580 |
| Device Name: | STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | Ethicon, Inc Route 22 West, P.O. Box 151 Somerville, NJ 00876 -0151 |
| Contact | Eleanor Zhou |
| Correspondent | Eleanor Zhou Ethicon, Inc Route 22 West, P.O. Box 151 Somerville, NJ 00876 -0151 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-09-19 |
| Decision Date | 2019-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705031465234 | K192580 | 000 |
| 30705031464395 | K192580 | 000 |
| 30705031464388 | K192580 | 000 |
| 30705031464371 | K192580 | 000 |
| 30705031464364 | K192580 | 000 |
| 30705031464357 | K192580 | 000 |
| 30705031464340 | K192580 | 000 |
| 30705031464333 | K192580 | 000 |
| 30705031464326 | K192580 | 000 |
| 30705031464319 | K192580 | 000 |
| 30705031464302 | K192580 | 000 |
| 30705031464296 | K192580 | 000 |
| 30705031464289 | K192580 | 000 |
| 30705031464401 | K192580 | 000 |
| 30705031464418 | K192580 | 000 |
| 20705031465128 | K192580 | 000 |
| 20705031465111 | K192580 | 000 |
| 20705031465104 | K192580 | 000 |
| 20705031465098 | K192580 | 000 |
| 20705031465081 | K192580 | 000 |
| 20705031465074 | K192580 | 000 |
| 30705031464487 | K192580 | 000 |
| 30705031464470 | K192580 | 000 |
| 30705031464463 | K192580 | 000 |
| 30705031464456 | K192580 | 000 |
| 30705031464432 | K192580 | 000 |
| 30705031464425 | K192580 | 000 |
| 30705031464272 | K192580 | 000 |