Injection Needle— 510(k) K260262
Substantially EquivalentMirco-Tech (Nanjing) Co., Ltd.
FDA 510(k) clearance K260262 for Injection Needle, Substantially Equivalent on 2026-05-29. Applicant: Mirco-Tech (Nanjing) Co., Ltd.. Device class: 2.
Summary
Mirco-Tech (Nanjing) filed the Injection Needle under FBK, endoscopic injection needles for gastroenterology-urology. The device name is generic.
Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
The company is in Nanjing, China. The decision came 121 calendar days after receipt (January 28 to May 29, 2026).
Clearance details
- Applicant
- Mirco-Tech (Nanjing) Co., Ltd.
- Product code
- Product code FBK
- 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 FBK
view allMore clearances from Mirco-Tech (Nanjing) Co., Ltd.
view allAdverse events under product code FBK
product code FBK- Other
- 1
- Total
- 1
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.