510(k) K143299 ยท GCJ Laparoscope, General & Plastic Surgery
Percuvance(R) Percutaneous Surgical System
| Applicant | Teleflexmedical, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Jan 21, 2015 |
| Received | Nov 17, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143299
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2016 | Teleflex Medical Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709
The Percutaneous Surgical System with 5 mm attachments is indicated fo Terminated |
GCJ | None listed |
| Oct 7, 2016 | Teleflex Medical Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709
The Percutaneous Surgical System with 5 mm attachments is indicated for Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.