Disposable Hemoclip
FDA 510(k) clearance K230004 · decided 2023-07-31
Clearance details
- K-number
- K230004
- Device name
- Disposable Hemoclip
- Applicant
- Yangzhou Fartley Medical Instrument Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-01-03
- Decision date
- 2023-07-31
- Days to decision
- 209 days
- Clearance type
- Traditional
- Product code
- PKL
- Device class
- 2
- Regulation number
- 876.4400
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Yangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.