WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE
FDA 510(k) clearance K942630 · decided 1994-07-12
Clearance details
- K-number
- K942630
- Device name
- WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE
- Applicant
- Mill-Rose Laboratory
- Decision
- Substantially Equivalent
- Date received
- 1994-06-03
- Decision date
- 1994-07-12
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mentor, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Mill-Rose Laboratory
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.