SINGLE USE ASPIRATION NEEDLE NA-201SX-4022
FDA 510(k) clearance K050503 · decided 2005-05-12
Clearance details
- K-number
- K050503
- Device name
- SINGLE USE ASPIRATION NEEDLE NA-201SX-4022
- Applicant
- Olympus Medical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2005-02-28
- Decision date
- 2005-05-12
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- FCG
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Melville, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Olympus Medical Systems Corporation
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
| Record | Firm | Date |
|---|---|---|
| OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Ne recall (Z-0029-2012) | Olympus America Inc. | 2011-10-07 |