Cleared Traditional

SPROTTE NRFit, Quincke NRFit

K160295 · PAJUNK GmbH Medizintechnologie · Anesthesiology
Oct 2016
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K160295 is an FDA 510(k) clearance for the SPROTTE NRFit, Quincke NRFit, a Needle, Conduction, Anesthetic (w/wo Introducer) (Class II — Special Controls, product code BSP), submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on October 27, 2016, 267 days after receiving the submission on February 3, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number K160295 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2016
Decision Date October 27, 2016
Days to Decision 267 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSP — Needle, Conduction, Anesthetic (w/wo Introducer)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5150

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