PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)— 510(k) K131902
Substantially EquivalentPentax Medical Company
FDA 510(k) clearance K131902 for PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY), Substantially Equivalent on 2014-04-10. Applicant: Pentax Medical Company. Device class: 2.
Clearance details
- Applicant
- Pentax Medical Company
- Product code
- Code FDS
- 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 FDS
view allMore clearances from Pentax Medical Company
view allAdverse events under product code FDS
product code FDS- Death
- 37
- Injury
- 863
- Malfunction
- 56,442
- Other
- 1
- Total
- 57,343
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 K131902
K-number listed on FDA's recall record- Z-0318-2017 — Pentax Video Gastroscope 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 upper digestive tract including the esophagus, stomach and duodenum.
- Z-2071-2016 — Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth 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 K131902.
Data sourced from openFDA. This site is unofficial and independent of the FDA.