510(k) K152317 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Stretta Catheter
| Applicant | Mederi Therapeutics, Inc., Norwalk CT, US |
| Decision | Substantially Equivalent, Sep 23, 2015 |
| Received | Aug 17, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152317
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2017 | Mederi Therapeutics, Inc Mederi Stretta Catheter and Accessory Kit, Sterile
For Use with the MEDERI MDRF1 GENERATOR ONLY.
Used in the treatment of gastroesophageal reflux disease (GERD).
REF 175-5580 Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.