510(k) K904800

SIF-SW by Olympus Corp. — Product Code FDA

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

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)
K071254 — SMALL INTESTINAL VIDEOSCOPE SYSTEM (March 25, 2008)