510(k) K042140
K042140 is an FDA 510(k) premarket notification submitted by Olympus Corporation for the device "OLYMPUS BF TYPE UC160-OL8". The FDA issued a decision of Substantially Equivalent on August 18, 2004. The device falls under product code ODG (Endoscopic Ultrasound System, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Olympus Corporation has at least 4 other 510(k) clearances on record.
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).