Disposable Injection Needles
FDA 510(k) clearance K232200 · decided 2024-04-12
Clearance details
- K-number
- K232200
- Device name
- Disposable Injection Needles
- Applicant
- Ningbo Xinwell Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-07-25
- Decision date
- 2024-04-12
- Days to decision
- 262 days
- Clearance type
- Traditional
- Product code
- FBK
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Ningbo Cixi, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ningbo Xinwell Medical Technology Co.
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.