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510(k) K042140

OLYMPUS BF TYPE UC160-OL8 by Olympus Corporation — Product Code ODG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2004
Date Received
August 9, 2004
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).

Other clearances by Olympus Corporation

  • K072643 — CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US (November 16, 2007)
  • K043128 — OLYMPUS ENDOARM (December 21, 2004)
  • K041494 — OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UC (July 1, 2004)
  • K040940 — BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM (April 19, 2004)

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