Polypectomy Snare— 510(k) K150316
Substantially EquivalentMicro-Tech (Nanjing) Co., Ltd.
FDA 510(k) clearance K150316 for Polypectomy Snare, Substantially Equivalent on 2015-07-30. Applicant: Micro-Tech (Nanjing) Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Micro-Tech (Nanjing) Co., Ltd.
- Product code
- Code FDI
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nanjing, CN
Recent devices under product code FDI
view allMore clearances from Micro-Tech (Nanjing) Co., Ltd.
view all- K252492 — Visualized Access and Delivery Catheter; PB Digital Controller
- K250229 — Dual Action Tissue Closure Device
- K243388 — Disposable Distal Cap
- K243471 — Extraction Basket
- K230127 — Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible
Adverse events under product code FDI
product code FDI- Death
- 6
- Injury
- 217
- Malfunction
- 1,544
- Total
- 1,767
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.