510(k) K062779 ยท GCJ Laparoscope, General & Plastic Surgery
DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)
| Applicant | New Wave Surgical Corporation, Great Neck NY, US |
| Decision | Substantially Equivalent, Oct 5, 2006 |
| Received | Sep 18, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062779
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2016 | Medtronic Covidien Clearify Visualization System
Item Code: 21-345
Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens Terminated |
FEI | None listed |
| Oct 4, 2016 | Medtronic Best Practices kits containing certain production lots of Clearify Visualization System
Item Code: 21-345
Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fog Terminated |
FEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.