PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)— 510(k) K251256
Substantially EquivalentPentax of America, Inc.
FDA 510(k) clearance K251256 for PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family), Substantially Equivalent on 2025-12-16. Applicant: Pentax of America, Inc.. Device class: 2.
Clearance details
- Applicant
- Pentax of America, Inc.
- 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 of America, Inc.
view all- K251127 — PENTAX Medical Video Processor (EPK-i8020c)
- K242110 — PENTAX Medical Video Colonoscope (EC38-i20cWL)
- K241213 — PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)
- K233942 — PENTAX Medical Video Duodenoscope (ED34-i10T2s) +3 more
- K240457 — C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.