510(k) K021808 ยท FZP Clip, Implantable
WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER
| Applicant | Weck, Durham NC, US |
| Decision | Substantially Equivalent, Aug 14, 2002 |
| Received | Jun 3, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021808
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2019 | Teleflex Medical WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965
Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer l Open, Classified |
FZP | None listed |
| Sep 16, 2008 | Telefelx Medical Weck Hemoclip Traditional Ligating Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709 USA. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and intended for Terminated |
FZP | None listed |
| Sep 16, 2008 | Telefelx Medical Weck Hemoclip Plus Ligating Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709 USA. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and intended for the appl Terminated |
FZP | None listed |
| Sep 16, 2008 | Telefelx Medical Weck , Horizon Titanium Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709, USA. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and intended for the applic Terminated |
FZP | None listed |
| Sep 16, 2008 | Telefelx Medical WECK Hem-o-lok Non-absorbable Polymer Ligation Clips, Rx Only, Sterile, Teleflex Medical, RTC, NC 27709. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and inten Terminated |
FZP | None listed |
| Sep 16, 2008 | Telefelx Medical WECK HemoClip Auto, Rx Only, Sterile, Teleflex Medical, RTC, NC 27709. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and intended for the application of hemosta Terminated |
FZP | None listed |
| Jun 9, 2006 | Teleflex Medical Weck Hem-o-lok Endo 5 Automatic Clip Applier with Medium Polymer Ligating Clips; Rx, sterile, single use, disposable clip applier with medium size, non-absorbable polymer ligation clips; 15 clips per Terminated |
FZP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.