510(k) K131855 ยท FDF Colonoscope And Accessories, Flexible/Rigid
PENTAX VIDEO COLONOSCOPES (EC FAMILY)
| Applicant | Pentax Medical Company, Montvale NJ, US |
| Decision | Substantially Equivalent, Apr 9, 2014 |
| Received | Jun 21, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131855
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2021 | Pentax of America Inc Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel
Models:
EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, Open, Classified |
FDF | None listed |
| Jul 14, 2021 | Pentax of America Inc Gastroscope Family # 1-Gastroscopes without a Water Jet Channel
Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10;
Gastroscope Family # 2- Gastroscopes with a Water Jet Channel
Models: EG-2990i Open, Classified |
FDF | None listed |
| Jan 3, 2020 | Pentax of America Inc Pentax Video Colonoscope
Model: EC34-i10L Terminated |
FDF | None listed |
| Jan 3, 2020 | Pentax of America Inc Pentax Video Colonoscope
Model: EC38-i10L Terminated |
FDF | None listed |
| Nov 19, 2016 | Pentax of America Inc Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancilla Terminated |
FDF | None listed |
| Jun 28, 2016 | Pentax Medical Company Colonoscope
Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems Terminated |
FDF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.