Cleared Traditional

K170435 - NerveGuard NRFit, NerveGuard LUER

K170435 is an FDA 510(k) clearance for NerveGuard NRFit, manufactured by PAJUNK GmbH Medizintechnologie. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K170435 · PAJUNK GmbH Medizintechnologie · Anesthesiology device
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Jul 2017
Decision
149d
Days
Class 2
Risk

K170435 is an FDA 510(k) clearance for the NerveGuard NRFit, NerveGuard LUER. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on July 12, 2017 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5150 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all PAJUNK GmbH Medizintechnologie devices

FDA 510(k) Submission Details - K170435

510(k) Number K170435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2017
Decision Date July 12, 2017
Days to Decision 149 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 140d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSP Device Classification - Class 2, Special Controls

Product Code BSP Needle, Conduction, Anesthetic (w/wo Introducer)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BSP Needle, Conduction, Anesthetic (w/wo Introducer)

All 105
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K170435.
EchoGlo Needle
K171968 · Smiths Medical Asd, Inc. · Jan 2018
Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles
K171518 · Zhejiang Kindly Medical Devices Co., Ltd. · Jan 2018
Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford
K163292 · Spectra Medical Devices · Sep 2017
Pinpoint GT Needles
K163216 · C.R. Bard, Inc. · Jun 2017
Entellus Medical Reinforced Anesthesia Needle
K163435 · Entellus Medical, Inc. · Apr 2017
Tuohy NRFit
K160297 · PAJUNK GmbH Medizintechnologie · Oct 2016