Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles— 510(k) K171518
Substantially EquivalentZhejiang Kindly Medical Devices Co., Ltd.
FDA 510(k) clearance K171518 for Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles, Substantially Equivalent on 2018-01-05. Applicant: Zhejiang Kindly Medical Devices Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Zhejiang Kindly Medical Devices Co., Ltd.
- Product code
- Code BSP
- Device class
- Class 2
- Regulation
- 21 CFR 868.5150
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wenzhou, CN
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Adverse events under product code BSP
product code BSP- Death
- 2
- Total
- 2
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.