510(k) K163492
K163492 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. for the device "Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear". The FDA issued a decision of Substantially Equivalent on January 6, 2017. The device falls under product code FDF (Colonoscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. United States Endoscopy Group, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 2017
- Date Received
- December 13, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colonoscope And Accessories, Flexible/Rigid
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To examine or perform procedures in the colon or rectum 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).