Cleared Traditional

K152699 - Apollo System

K152699 is the FDA 510(k) clearance for Apollo System by Penumbra, Inc.. It is a Class 2 Neurology device (product code GWG) cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K152699 · Penumbra, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
178d
Days
Class 2
Risk

K152699 is an FDA 510(k) clearance for the Apollo System. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on March 17, 2016 after a review of 178 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1480 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Penumbra, Inc. devices

Submission Details

510(k) Number K152699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2015
Decision Date March 17, 2016
Days to Decision 178 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 148d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWG Endoscope, Neurological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1480
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Neurology devices follow this clearance model.

Regulatory Peers - GWG Endoscope, Neurological

All 47
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K152699.
KARL STORZ ShuntScope
K170462 · KARL STORZ Endoscopy-America, Inc. · May 2017
TIPCAM 1S 3D System
K162880 · KARL STORZ Endoscopy-America, Inc. · Mar 2017
KARL STORZ Flexible Video-Neuro-Endoscope System
K161112 · KARL STORZ Endoscopy-America, Inc. · Sep 2016
MINOP Disposable Introducer 26F
K142315 · Aesculap, Inc. · Nov 2014
APOLLO SYSTEM
K132931 · Penumbra, Inc. · Jan 2014
KSEA CLEARVISION II, MODEL 40334120
K072410 · KARL STORZ Endoscopy-America, Inc. · May 2008