Cleared Traditional

Entellus Medical Reinforced Anesthesia Needle (K163435) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163435 · Entellus Medical, Inc. · Anesthesiology device
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Apr 2017
Decision
119d
Days
Class 2
Risk

K163435 is an FDA 510(k) clearance for the Entellus Medical Reinforced Anesthesia Needle. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Entellus Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on April 5, 2017 after a review of 119 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 Entellus Medical, Inc. devices

Submission Details

510(k) Number K163435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2016
Decision Date April 05, 2017
Days to Decision 119 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 140d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 44
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K163435.
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
Pinpoint GT Needles
K163216 · C.R. Bard, Inc. · Jun 2017
PERICAN ULTRA
K133632 · B.Braun Medical, Inc. · Jun 2014
CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE
K121846 · B.Braun Medical, Inc. · Nov 2012
PENCAN SPINAL NEEDLE
K112515 · B.Braun Medical, Inc. · Dec 2011