510(k) K112456 ยท GCJ Laparoscope, General & Plastic Surgery
ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT
| Applicant | Teleflexmedical, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Oct 4, 2011 |
| Received | Aug 25, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112456
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2014 | Teleflex Medical 5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 410944, 5/10 Weck Vista Universal Balloon Open Access Port - Long Length (100mm), Catalog No. 410944L; 5/10 Wec Terminated |
GCJ | None listed |
| Mar 25, 2014 | Teleflex Medical 5/10 Weck Vista" Universal Balloon Open Access Port - Standard Length (70mm),
Product Usage:
An endoscope and accessories is a device used to provide access, illumination, and allow observation or Terminated |
GCJ | None listed |
| Mar 25, 2014 | Teleflex Medical 5/10 Weck Vista" Universal Balloon Open Access Port - Long Length (100mm),
Product Usage:
An endoscope and accessories is a device used to provide access, illumination, and allow observation or ma Terminated |
GCJ | None listed |
| Mar 25, 2014 | Teleflex Medical 5/10 Weck Vista" Universal Balloon Open Access Port Short Length (53mm),
Product Usage:
An endoscope and accessories is a device used to provide access, illumination, and allow observation or man Terminated |
GCJ | None listed |
| Mar 25, 2014 | Teleflex Medical 5/10/12 Weck Vista" Universal Balloon Open Access Port Standard Length (70mm),
Product Usage:
An endoscope and accessories is a device used to provide access, illumination, and allow observation Terminated |
GCJ | None listed |
| Mar 25, 2014 | Teleflex Medical 5/10/12 Weck Vista" Universal Balloon Open Access Port Long Length (100mm),
Product Usage:
An endoscope and accessories is a device used to provide access, illumination, and allow observation or m Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.