TULA Tube Delivery System
FDA 510(k) clearance K171239 · decided 2017-06-28
Clearance details
- K-number
- K171239
- Device name
- TULA Tube Delivery System
- Applicant
- Tusker Medical
- Decision
- Substantially Equivalent
- Date received
- 2017-04-27
- Decision date
- 2017-06-28
- Days to decision
- 62 days
- Clearance type
- Special
- Product code
- ETD
- Device class
- 2
- Regulation number
- 874.3880
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Menlo Park, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Tusker Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.