EC-3800L Video Colonoscope

• • Terminated Z-2068-2016 FDA Class II ·initiated 6 Apr 2016

  Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

• 2 recalls, same reason

  • Terminated Z-2275-2016 FDA Class II ·initiated 6 Apr 2016
  • Terminated Z-2278-2016 FDA Class II ·initiated 6 Apr 2016

  Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

510(k) Number

K951574 ↗

FDA Product Code

FDF

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Fe-34TH, Fiber Esophagoscope

  Class II

  FDA 510(k) K951198 Active Cleared 30 May 1995

• Eg-3630UR, Ultrasund Video Gastroscope

  Class II

  FDA 510(k) K013640 Active Cleared 4 Feb 2002

• Fs-38X, Fiber Sigmoidoscope

  Class II

  FDA 510(k) K951572 Active Cleared 27 Jun 1995

• Kec-3840l/F, Video Colonoscope (*l or F in Model Number Denotes Length)

  Class II

  FDA 510(k) K961570 Active Cleared 24 Jun 1996

• Fcp-9P, Fiber Choledochoscope

  Class II

  FDA 510(k) K953286 Active Cleared 3 Nov 1995

• Fi-10P

  Class I

  FDA 510(k) K951195 Active Cleared 6 Apr 1995

See all devices from Pentax Precision Instrument Corp. →

• Is the EC-3800L Video Colonoscope reusable or intended for single-use in clinical settings?

  The EC-3800L Video Colonoscope is explicitly designed for single-use in clinical settings. This is confirmed by the manufacturer’s description, which states it is supplied sterile and intended for one-time use to ensure patient safety and hygiene.

• What components are included with the EC-3800L Video Colonoscope when it is supplied?

  The EC-3800L comes as a complete package, including a flexible insertion tube, a control body, and an umbilicus for operation. These components work together to enable the visual examination of the colon.

• How is the EC-3800L Video Colonoscope used in clinical practice?

  The EC-3800L is paired with a video processor to display real-time imaging of the colon’s mucosal lining. This electronic imaging system helps clinicians diagnose conditions like polyps, tumors, or inflammatory diseases by providing clear visualization during the procedure.

• What regulatory pathway was followed for the EC-3800L Video Colonoscope’s clearance?

  The EC-3800L received FDA 510(k) clearance under the traditional review pathway, demonstrating substantial equivalence to a predicate device. It is classified as a Class II medical device under FDA regulation 876.1500 and was reviewed by the Gastroenterology and Urology (GU) Advisory Committee.