510(k) K153611 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device
| Applicant | Ethicon, LLC, Los Frailes Industrial Park, Suite 401 PR, US |
| Decision | Substantially Equivalent, Jun 3, 2016 |
| Received | Dec 17, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153611
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.