OLYMPUS AF ANGIOSCOPE SYSTEM— 510(k) K911278

Substantially Equivalent

Olympus Corp.

FDA 510(k) clearance K911278 for OLYMPUS AF ANGIOSCOPE SYSTEM, Substantially Equivalent on 1991-07-17. Applicant: Olympus Corp.. Device class: 2.

Clearance details

Applicant: Olympus Corp.
Product code: Code LYK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1991-03-25
Decision date: 1991-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYK

K253842 — Vena MicroAngioscope System2026-01-28
K251767 — Vena MicroAngioscope System2025-10-01
K062340 — CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM2006-11-30
K050808 — CORONARY SINUS ACCESS KIT, MODEL KCS8F-012005-07-28
K011793 — KSEA FIBERSCOPE2002-04-17

More clearances from Olympus Corp.

K915402 — EW-10 AND EW-201995-06-23
K933200 — OLYMPUS PBD STENTS1995-04-05
K942338 — OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES1994-11-30
K931763 — HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS1994-08-29
K934835 — FLOVAL1994-06-21

Recalls naming K911278

K-number listed on FDA's recall record

Z-0330-2024 — Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.Class III·Ongoing·Aizu Olympus Co., Ltd.·20230925

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K911278.

Data sourced from openFDA. This site is unofficial and independent of the FDA.