Disposable Trocars
FDA 510(k) clearance K250820 · decided 2025-07-11
Clearance details
- K-number
- K250820
- Device name
- Disposable Trocars
- Applicant
- Sinolinks Medical Innovation, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-03-18
- Decision date
- 2025-07-11
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Changzhou, Jiangsu, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.