510(k) K210485 ยท FDS Gastroscope And Accessories, Flexible/Rigid
PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)
| Applicant | Pentax of America, Inc., Montvale NJ, US |
| Decision | Substantially Equivalent, May 13, 2021 |
| Received | Feb 19, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210485
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.