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510(k) K010591

OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER by Olympus Optical Co., Ltd. — Product Code ODG

K010591 is an FDA 510(k) premarket notification submitted by Olympus Optical Co., Ltd. for the device "OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER". The FDA issued a decision of Substantially Equivalent on March 15, 2001. The device falls under product code ODG (Endoscopic Ultrasound System, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Olympus Optical Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2001
Date Received
February 28, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Olympus Optical Co., Ltd.

  • K033225 — EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND AN (October 16, 2003)
  • K031305 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (September 23, 2003)
  • K031648 — VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V (July 24, 2003)
  • K032092 — OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE (July 16, 2003)
  • K031347 — ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 (May 9, 2003)
  • K024138 — HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE (March 12, 2003)
  • K021852 — OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES (February 11, 2003)
  • K022445 — VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V (January 24, 2003)
  • K024033 — XTJF-160AF DUODENOVIDEOSCOPE (December 20, 2002)
  • K023280 — OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES (December 19, 2002)

Other clearances for product code ODG

  • K260428 — RIVOS™ EUS Access Device (M00553900) (June 17, 2026)
  • K251859 — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) (October 3, 2025)
  • 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)

FDA data resources