Ensure Single-Use Coagulation Forceps
FDA 510(k) clearance K202438 · decided 2021-03-15
Clearance details
- K-number
- K202438
- Device name
- Ensure Single-Use Coagulation Forceps
- Applicant
- Micro-Tech (Nanjing) Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-08-25
- Decision date
- 2021-03-15
- Days to decision
- 202 days
- Clearance type
- Traditional
- Product code
- KGE
- Device class
- 2
- Regulation number
- 876.4300
- 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.