510(k) K010591

OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER by Olympus Optical Co., Ltd. — Product Code ODG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 15, 2001
Date Received: February 28, 2001
Clearance Type: Traditional
Expedited Review: No
Third Party Review: Yes

Device Classification

Device Name: Endoscopic Ultrasound System, Gastroenterology-Urology
Device Class: Class II
Regulation Number: 876.1500
Review Panel: GU
Submission Type

To provide ultrasonic visualization of body cavities that can be accessed by endoscope. 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).

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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)

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