Device Listing 1502865216
Listing Summary#
- Listing key
- 1502865216
- Premarket submission
- K242699
- Device
- Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12)
- Applicant
- Opcom Medical, Inc.
- Product code
- FGB
- Decision date
- 2025-05-28