510(k) K090159 ยท GDW Staple, Implantable
INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES
| Applicant | Incisive Surgical, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Feb 6, 2009 |
| Received | Jan 22, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090159
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2015 | Incisive Surgical Inc Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgic Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.