510(k) K180579 ยท GCJ Laparoscope, General & Plastic Surgery
Ezee Retrieval
| Applicant | Genicon, Inc., Winter Park FL, US |
| Decision | Substantially Equivalent, Mar 19, 2018 |
| Received | Mar 5, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180579
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2018 | Genicon, Inc. Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction. Open, Classified |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.