Extraction Basket
FDA 510(k) clearance K243471 · decided 2024-12-16
Clearance details
- K-number
- K243471
- Device name
- Extraction Basket
- Applicant
- Micro-Tech (Nanjing) Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-11-08
- Decision date
- 2024-12-16
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- LQR
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Nanjing, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.