510(k) K042741 ยท GCJ Laparoscope, General & Plastic Surgery
EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE
| Applicant | Pentax Medical Company, Montvale NJ, US |
| Decision | Substantially Equivalent, Oct 19, 2004 |
| Received | Oct 4, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042741
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2016 | Pentax Medical Company Confocal GI Scope
Product Usage:
Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissue Terminated |
GCJ | None listed |
| Jun 28, 2016 | Pentax Medical Company Confocal GI Scope
Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.