K-PACK II NEEDLE- 27G & 30G THIN WALL
FDA 510(k) clearance K110850 · decided 2011-06-09
Clearance details
- K-number
- K110850
- Device name
- K-PACK II NEEDLE- 27G & 30G THIN WALL
- Applicant
- Terumo Europe N.V.
- Decision
- Substantially Equivalent
- Date received
- 2011-03-28
- Decision date
- 2011-06-09
- Days to decision
- 73 days
- Clearance type
- Special
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Leuven, BE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Terumo Europe N.V.
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.