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510(k) K933717

OLYMPUS MEASURING DEVICES by Olympus Corp. — Product Code FDS

K933717 is an FDA 510(k) premarket notification submitted by Olympus Corp. for the device "OLYMPUS MEASURING DEVICES". The FDA issued a decision of Substantially Equivalent on November 2, 1993. The device falls under product code FDS (Gastroscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. Olympus Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1993
Date Received
July 30, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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 Corp.

  • K915402 — EW-10 AND EW-20 (June 23, 1995)
  • K933200 — OLYMPUS PBD STENTS (April 5, 1995)
  • K942338 — OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES (November 30, 1994)
  • K931763 — HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS (August 29, 1994)
  • K934835 — FLOVAL (June 21, 1994)
  • K931764 — HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES (June 8, 1994)
  • K915857 — FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE (March 11, 1994)
  • K931994 — RESECTOSCOPE SHEATH (February 17, 1994)
  • K934889 — OLYMPUS IMAGEMANAGER SYSTEM (January 28, 1994)
  • K934888 — OLYMPUS IMAGEMANAGERSYSTEM (January 25, 1994)

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