510(k) K132375 ยท GCJ Laparoscope, General & Plastic Surgery
GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG
| Applicant | Genicon, Winter Park FL, US |
| Decision | Substantially Equivalent, Jun 12, 2014 |
| Received | Jul 30, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132375
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2015 | DeRoyal Industries Inc DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only
Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remo Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.