IMD's Lumbar Puncture Needle— 510(k) K170112

Name: FDA 510(k) clearance K170112
Creator: U.S. Food and Drug Administration
Published: 2018-02-02

Substantially Equivalent

International Medical Development, Inc.(Imd)

FDA 510(k) clearance K170112 for IMD's Lumbar Puncture Needle, Substantially Equivalent on 2018-02-02. Applicant: International Medical Development, Inc.(Imd). Device class: 2.

Clearance details

Applicant: International Medical Development, Inc.(Imd)
Product code: Code BSP
Device class: Class 2
Regulation: 21 CFR 868.5150
Advisory panel: Anesthesiology
Date received: 2017-01-12
Decision date: 2018-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntsville, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BSP

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K243690 — SonoMSK2025-07-01
K243682 — SonoPlex STIM; SonoPlex II2025-06-27
K250774 — SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture2025-06-25
K243525 — SonoTAP and SonoTAP II2025-03-24
K241953 — SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology2024-11-22

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.