Pentax Medical Video Colonoscope EC34-i10T Series
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180285 FDA 510(k)
- FDA Product Code
- FDF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pentax Medical Video Colonoscope EC34-i10T Series is a flexible endoscopic instrument designed for visualization of the lower gastrointestinal tract. It incorporates a distal insertion portion with a CCD camera, light guide, instrument channel, and air/water/suction ports, as well as a control body with angulation knobs and remote operation buttons for precise maneuvering.
The device is classified as a Class II colonoscope and accessories and was cleared through a traditional FDA 510(k) submission (K180285) as substantially equivalent. It is manufactured by Pentax Medical of America, Inc. and supplied as a complete colonoscope system; the regulatory data do not specify sterility status, single‑use or reusable designation, or MRI safety.
Frequently asked questions
What is the PENTAX EC34-i10T Video Colonoscope used for?
The PENTAX EC34-i10T Video Colonoscope is a flexible endoscopic instrument designed specifically for visualization of the lower gastrointestinal tract. It features a distal insertion portion with a CCD camera, light guide, instrument channel, and air/water/suction ports for comprehensive examination procedures.
How is the PENTAX EC34-i10T Video Colonoscope supplied?
The device is supplied as a complete colonoscope system by Pentax Medical of America, Inc. The regulatory data does not specify sterility status, single-use or reusable designation, or MRI safety information, so these details should be confirmed directly with the manufacturer.
What is the regulatory status of the PENTAX EC34-i10T Video Colonoscope?
The PENTAX EC34-i10T Video Colonoscope is classified as a Class II colonoscope and accessories and was cleared through a traditional FDA 510(k) submission (K180285) as substantially equivalent. It received FDA clearance on October 26, 2018.
What features does the PENTAX EC34-i10T Video Colonoscope have for maneuverability?
The colonoscope includes a control body with angulation knobs and remote operation buttons that allow for precise maneuvering during procedures. These features enable clinicians to navigate the lower gastrointestinal tract effectively and perform detailed examinations.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PENTAX Medical Video Colonoscope EC34-i10T Series, PDF RetroView Colonoscopes EC34-i10T - novomed-pal.com, PENTAX Medical Video Colonoscope EC34-i10T Series
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180285 | Class II | Active |
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Manufacturer
- Manufacturer
- Pentax Medical of America, Inc.
Sources (1)
- FDA 510(k) K180285 24 fields · synced Sep 25, 2026