CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE— 510(k) K924554

Name: FDA 510(k) clearance K924554
Creator: U.S. Food and Drug Administration
Published: 1993-02-25

Substantially Equivalent

Clarus Medical Systems, Inc.

FDA 510(k) clearance K924554 for CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE, Substantially Equivalent on 1993-02-25. Applicant: Clarus Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Clarus Medical Systems, Inc.
Product code: Code LYK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1992-09-09
Decision date: 1993-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYK

view all

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 Clarus Medical Systems, Inc.

view all

K980588 — CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 60001998-08-18
K974579 — PERCSCOPE MODEL 26001998-02-18
K971584 — CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)1997-05-23
K971455 — CLARUS MODEL 5197 SIGHTLITE1997-05-20
K960915 — CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX1996-12-24

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