510(k) K031256
K031256 is an FDA 510(k) premarket notification submitted by Olympus Opto-Electronics Co., Ltd. for the device "XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE". The FDA issued a decision of Substantially Equivalent on July 23, 2003. The device falls under product code FDA (Enteroscope And Accessories), a Class II device regulated under 21 CFR 876.1500. Olympus Opto-Electronics Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 2003
- Date Received
- April 21, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enteroscope And Accessories
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To provide visualization and perform various procedures within the small intestine. 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).