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510(k) K021886

OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P by Olympus Optical Co., Ltd. — Product Code FDS

K021886 is an FDA 510(k) premarket notification submitted by Olympus Optical Co., Ltd. for the device "OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P". The FDA issued a decision of Substantially Equivalent on June 19, 2002. The device falls under product code FDS (Gastroscope And Accessories, Flexible/Rigid), 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
June 19, 2002
Date Received
June 7, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Gastroscope And Accessories, Flexible/Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To examine or perform procedures in the stomach. 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 FDS

  • K261400 — Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large (September 16, 2026)
  • K260824 — Gastrointestinal Videoscope Olympus GIF-2T1500 (August 27, 2026)
  • K260856 — Disposable Distal Attachment D-201-13404 (August 27, 2026)
  • K253702 — Intuitive Endoluminal Gastrointestinal System (IG1000) (August 7, 2026)
  • K260573 — EvoEndo Single-Use Endoscopy System (April 21, 2026)
  • K250550 — FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit (February 17, 2026)
  • K253568 — Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; (February 6, 2026)
  • K251256 — PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Vid (December 16, 2025)
  • K251041 — GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 (October 31, 2025)
  • K251708 — EvoEndo Single-Use Endoscopy System (October 10, 2025)

FDA data resources