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510(k) K010740

FG-36UX, FIBER ULTRASOUND GASTROSCOPE by Pentax Precision Instrument Corp. — Product Code ODG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2001
Date Received
March 13, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Ultrasound System, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To provide ultrasonic visualization of body cavities that can be accessed by endoscope. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Pentax Precision Instrument Corp.

  • K041395 — EG-3630UR (June 9, 2004)
  • K041396 — FG-36UX FIBER ULTRASOUND GASTROSCOPE (June 9, 2004)
  • K041397 — EG-3830UT (June 9, 2004)
  • K031789 — EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE (August 8, 2003)
  • K023401 — EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE (February 11, 2003)
  • K023376 — EB-1830T3, VIDEO BRONCHOSCOPE (October 16, 2002)
  • K021276 — FG-36UX FIBER ULTRASOUND GASTROSCOPE (September 12, 2002)
  • K021278 — EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE (September 6, 2002)
  • K013640 — EG-3630UR, ULTRASUND VIDEO GASTROSCOPE (February 4, 2002)
  • K964815 — AP-4000, AIR PULSE SENSORY STIMULATOR (September 4, 1997)

Other clearances for product code ODG

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  • K251542 — InstaFAN (July 18, 2025)
  • K231813 — Ultrasonic Gastrovideoscope (March 8, 2024)
  • K232518 — EndoSound Vision System; EVS (December 27, 2023)
  • K223616 — Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (December 30, 2022)
  • K221238 — FUJIFILM Ultrasonic Endoscope EG-740UT (August 19, 2022)
  • K221952 — Endoscope Model EG-580UT and Endoscope Model EG-580UR (August 4, 2022)
  • K214089 — FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 (June 3, 2022)
  • K212852 — Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic (December 6, 2021)
  • K203166 — PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultraso (December 30, 2020)