Disposable Distal Cap— 510(k) K243388
Substantially EquivalentMicro-Tech (Nanjing) Co., Ltd.
FDA 510(k) clearance K243388 for Disposable Distal Cap, Substantially Equivalent on 2025-06-27. Applicant: Micro-Tech (Nanjing) Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Micro-Tech (Nanjing) Co., Ltd.
- Product code
- Code FDS
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nanjing, CN
Recent devices under product code FDS
view allMore clearances from Micro-Tech (Nanjing) Co., Ltd.
view all- K252492 — Visualized Access and Delivery Catheter; PB Digital Controller
- K251692 — Advanced Tissue Resection Device
- K250229 — Dual Action Tissue Closure Device
- 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 FDS
product code FDS- Death
- 37
- Injury
- 863
- Malfunction
- 56,442
- Other
- 1
- Total
- 57,343
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.