Endoscopic Injection Needles
FDA 510(k) clearance K240675 · decided 2024-10-04
Clearance details
- K-number
- K240675
- Device name
- Endoscopic Injection Needles
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-03-11
- Decision date
- 2024-10-04
- Days to decision
- 207 days
- Clearance type
- Traditional
- Product code
- FBK
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hangzhou City, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.