PENTAX VIDEO COLONOSCOPES (EC FAMILY)— 510(k) K131855
Substantially EquivalentPentax Medical Company
FDA 510(k) clearance K131855 for PENTAX VIDEO COLONOSCOPES (EC FAMILY), Substantially Equivalent on 2014-04-09. Applicant: Pentax Medical Company. Device class: 2.
Clearance details
- Applicant
- Pentax Medical Company
- Product code
- Code FDF
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montvale, NJ, US
Recent devices under product code FDF
view allMore clearances from Pentax Medical Company
view allAdverse events under product code FDF
product code FDF- Death
- 8
- Injury
- 729
- Malfunction
- 61,773
- Total
- 62,510
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K131855
K-number listed on FDA's recall record- Z-2448-2021 — 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, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK
- Z-2449-2021 — 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, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Instrument Channels and a Water Jet Channel Models: EG-3890TK
- Z-1267-2020 — Pentax Video Colonoscope Model: EC34-i10L
- Z-1268-2020 — Pentax Video Colonoscope Model: EC38-i10L
- Z-0636-2017 — 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 ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
- Z-2068-2016 — 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: Large Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131855.
Data sourced from openFDA. This site is unofficial and independent of the FDA.