Injection Needle— 510(k) K150434

Clearance details

Applicant

Micro-Tech (Nanjing) Co., Ltd.

Product code

Code FBK

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2015-02-19

Decision date

2015-06-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Nanjing, CN

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Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →