510(k) K132472 ยท GDW Staple, Implantable
JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD
| Applicant | Justright Surgical, LLC, Newbury NH, US |
| Decision | Substantially Equivalent, Feb 11, 2014 |
| Received | Aug 7, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132472
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2014 | Justright Surgical, LLC Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cases of 6.
The JustRight 5mm Stapler is intended for use in abdominal, gynecologi Terminated |
GDW | None listed |
| Sep 23, 2014 | Justright Surgical, LLC Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only
It is a replacement cartridge used when more than one firing is required during a surgery. Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.