Pentax of America, Inc. · Class II · Cleared Dec 16, 2025
| K-number | K251256 |
| Device name | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) |
| Applicant | Pentax of America, Inc. |
| Product code | FDS |
| Device class | Class II |
| Decision date | Dec 16, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
PENTAX Medical Video Upper GI Scopes (EG Family) and Video Colonoscopes (EC Family) are flexible endoscopes used with a video processor, light source, and ancillary equipment to visualize and perform endoscopic surgery in the upper digestive tract (esophagus, stomach, duodenum) and lower digestive tract (anus, rectum, colon, ileocecal valve), respectively.
The subject devices are identical to predicate devices in fundamental technology, operating principles, intended use, and design (insertion portion, control body, fiberoptic illumination). Changes are limited to labeling updates, reprocessing procedure modifications, mechanical modifications for IEC 60601-1-2 compliance, and patient-contact material changes with no impact on overall performance or functionality.
IEC 60601-1-2:2014 + A1:2020; IEC 60601-1:2005 + A1:2012 + A2:2020; IEC 60601-1-6:2010 + A1:2013 + A2:2020; IEC 60601-2-18:2009; AAMI ST98:2022; FDA 2015 Reprocessing Guidance; FDA 2016 Human Factors guidance.
The subject devices are substantially equivalent because they have identical intended use, indications for use, and technological characteristics to predicate devices K131902 and K131855. Minor changes (labeling, reprocessing procedures, mechanical modifications for EMC compliance, and material substitutions) have been validated through performance testing with no safety or effectiveness concerns, and do not impact device functionality or intended use.
View the full FDA submission: accessdata.fda.gov