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510(k) K904800

SIF-SW by Olympus Corp. — Product Code FDA

K904800 is an FDA 510(k) premarket notification submitted by Olympus Corp. for the device "SIF-SW". The FDA issued a decision of Substantially Equivalent on March 27, 1991. The device falls under product code FDA (Enteroscope And Accessories), 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
March 27, 1991
Date Received
October 24, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enteroscope And Accessories
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To provide visualization and perform various procedures within the small intestine. 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 FDA

  • K260314 — Ancora-SB (May 1, 2026)
  • K251204 — FUJIFILM Stiffening Wire Device (SW-2000) (September 26, 2025)
  • K233321 — Double Balloon Endoscope EN-840T, Over-tube TS-1214C (June 13, 2024)
  • K231323 — Ancora-SB (August 31, 2023)
  • K223295 — Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D (January 11, 2023)
  • K213195 — Balloon BS-3 (October 29, 2021)
  • K191330 — Arc Enterocuff (January 31, 2020)
  • K183032 — FUJIFILM Double Balloon Endoscope EI580BT (June 24, 2019)
  • K183683 — FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 (February 27, 2019)
  • K143556 — Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T (August 20, 2015)

FDA data resources