510(k) K153063 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM
| Applicant | Teleflexmedical, Inc., Morrisville NC, US |
| Decision | Substantially Equivalent, Apr 8, 2016 |
| Received | Oct 22, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153063
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 3, 2018 | Teleflex Medical Percuvance(R) Percutaneous Shaft 29cm, PCVSH3
The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft tissue to access certain areas of the ab Terminated |
GEI | None listed |
| Jan 3, 2018 | Teleflex Medical Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3
The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft tissue to access certain areas of the a Terminated |
GEI | None listed |
| Oct 18, 2017 | Teleflex Medical Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components:
(a) 5 mm Atraumatic Johans Grasper, Catalog Number PCVJG5
(b) 5 mm Maryland Dissector, Catalog Number PCVMD5
(c) 5 mm Hem-o-lok Terminated |
GEI | None listed |
| Jul 19, 2017 | Teleflex Medical Percuvance Gripper Grasper Tool Tip
The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is us Terminated |
GEI | None listed |
| Jul 19, 2017 | Teleflex Medical Percuvance Clip Applier Tool Tip
The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used Terminated |
GEI | None listed |
| Jul 19, 2017 | Teleflex Medical Percuvance Johans Grasper Tool Tip
The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is use Terminated |
GEI | None listed |
| Jul 19, 2017 | Teleflex Medical Percuvance Maryland Dissector Tool Tip
The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is Terminated |
GEI | None listed |
| Jul 19, 2017 | Teleflex Medical Percuvance Scissors Tool Tip
The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to g Terminated |
GEI | None listed |
| Jul 19, 2017 | Teleflex Medical Percuvance 29cm Shaft
The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, m Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.