The following data is part of a premarket notification filed by Ethicon, Llc with the FDA for Coated Vicryu (polyglactin 91o)sterile Synthetic Absorbable Suture Cartridges, Ethibond Polybutilate Coated Polyester Sterile Synthetic Non-absorbable Suture Cartridges, Proxisure Suturing Device.
| Device ID | K153611 |
| 510k Number | K153611 |
| Device Name: | Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | Ethicon, LLC 475 C Street Los Frailes Industrial Park, Suite 401, PR 00969 |
| Contact | Marjorie Medina |
| Correspondent | Rubina Dosani Ethicon Endo-Surgery, Inc 4545 Creek Road Cincinnati, OH 45242 |
| Product Code | GAM |
| Subsequent Product Code | GAT |
| Subsequent Product Code | OCW |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-17 |
| Decision Date | 2016-06-03 |
| Summary: | summary |