Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder— 510(k) K172763
Substantially EquivalentZhejiang Kindly Medical Devices Co., Ltd.
FDA 510(k) clearance K172763 for Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder, Substantially Equivalent on 2018-06-04. Applicant: Zhejiang Kindly Medical Devices Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Zhejiang Kindly Medical Devices Co., Ltd.
- Product code
- Product code JKA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wenzhou, CN
Recent devices under product code JKA
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- K262215 — Profoject Safety Sliding Blood Collection Set
- K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device
More clearances from Zhejiang Kindly Medical Devices Co., Ltd.
view allAdverse events under product code JKA
product code JKA- Injury
- 455
- Malfunction
- 26,686
- Other
- 4
- Total
- 27,145
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.