Device Listing 1194053068
Listing Summary#
- Listing key
- 1194053068
- Premarket submission
- K163492
- 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
- Applicant
- United States Endoscopy Group, Inc.
- Product code
- FDF
- Decision date
- 2017-01-06