FDA 510(k), K202438, Ensure Single-Use Coagulation Forceps
FDA 510(k), K202438, Ensure Single-Use Coagulation Forceps
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510(K) Number: K202438
Device Name: Ensure Single-Use Coagulation Forceps
Manufacturer: Micro-Tech (Nanjing) Co., Ltd.
Device Classification Name: forceps, biopsy, electric
Regulation Number: 876.4300
Classification Product Code: KGE
Date Received: 08/25/2020
Decision Date: 03/15/2021
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Ensure Single-Use Coagulation Forceps
Manufacturer: Micro-Tech (Nanjing) Co., Ltd.
Device Classification Name: forceps, biopsy, electric
Regulation Number: 876.4300
Classification Product Code: KGE
Date Received: 08/25/2020
Decision Date: 03/15/2021
Regulation Medical Specialty: Gastroenterology/Urology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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