510(k) K021204

OLYMPUS BF TYPE UM40 by Olympus Optical Co., Ltd. — Product Code PSV

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 1, 2002
Date Received: April 16, 2002
Clearance Type: Traditional
Expedited Review: No
Third Party Review: Yes

Device Classification

Device Name: Ultrasound Bronchoscope
Device Class: Class II
Regulation Number: 892.1550
Review Panel: EN
Submission Type

An ultrasound bronchoscope is indicated for the ultrasonic visualization, diagnosis and therapeutic access to the bronchial tree or the lungs. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type 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 Optical Co., Ltd.

K033225 — EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND AN (October 16, 2003)
K031305 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (September 23, 2003)
K031648 — VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V (July 24, 2003)
K032092 — OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE (July 16, 2003)
K031347 — ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 (May 9, 2003)
K024138 — HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE (March 12, 2003)
K021852 — OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES (February 11, 2003)
K022445 — VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V (January 24, 2003)
K024033 — XTJF-160AF DUODENOVIDEOSCOPE (December 20, 2002)
K023280 — OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES (December 19, 2002)

510(k) K021204

Clearance Details

Device Classification

Other clearances by Olympus Optical Co., Ltd.

Other clearances for product code PSV