Dr J Spinal and Epidural Needles— 510(k) K183316

Name: FDA 510(k) clearance K183316
Creator: U.S. Food and Drug Administration
Published: 2019-08-12

Substantially Equivalent

Dr. Japan Co., Ltd.

FDA 510(k) clearance K183316 for Dr J Spinal and Epidural Needles, Substantially Equivalent on 2019-08-12. Applicant: Dr. Japan Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dr. Japan Co., Ltd.
Product code: Code BSP
Device class: Class 2
Regulation: 21 CFR 868.5150
Advisory panel: Anesthesiology
Date received: 2018-11-30
Decision date: 2019-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BSP

product code BSP

Death: 2
Total: 2

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.