Pentax Flexible Driodenofiberscope

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K812810 ↗

FDA Product Code

FAK

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. →

• What types of procedures is the Pentax Flexible Driodenofiberscope primarily used for in clinical settings?

  The Pentax Flexible Driodenofiberscope is designed for flexible endoscopic examination of the upper gastrointestinal tract, including the esophagus, stomach, and duodenum. It is used for both diagnostic and therapeutic procedures in gastroenterology and urology, such as visualizing internal structures, obtaining biopsies, or performing minor interventions like polyp removal.

• Is this device single-use or reusable, and what maintenance is required between uses?

  This device is reusable and must undergo thorough cleaning, disinfection, and sterilization between uses to ensure safety and functionality. Proper maintenance is critical to preserve its performance and prevent cross-contamination in clinical settings like hospitals or endoscopy units.

• How was the regulatory approval process for this device structured, and which advisory committee reviewed it?

  The Pentax Flexible Driodenofiberscope was cleared under the FDA’s 510(k) pathway (K812810) in 1981 through a Traditional 510(k) review, meaning it was compared to a legally marketed predicate device. The Gastroenterology and Urology (GU) Advisory Committee reviewed the submission before clearance, as it falls under the classification for Panendoscopes (Gastroduodenoscopes) in 21 CFR 876.1500.

• What clinical specialties would benefit most from using this device, and why?

  This device is primarily intended for use in gastroenterology and urology due to its design for examining the upper gastrointestinal tract (esophagus, stomach, and duodenum). Clinicians in these specialties rely on it for diagnostic imaging, therapeutic interventions, and procedural guidance where real-time visualization is essential.