Cleared Traditional

K171402 - KARL STORZ Slim Nasopharyngolaryngoscope

K171402 is an FDA 510(k) clearance for KARL STORZ Slim Nasopharyngolaryngoscope, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOB cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K171402 · KARL STORZ Endoscopy-America, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
266d
Days
Class 2
Risk

K171402 is an FDA 510(k) clearance for the KARL STORZ Slim Nasopharyngolaryngoscope. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on February 2, 2018 after a review of 266 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4760 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all KARL STORZ Endoscopy-America, Inc. devices

FDA 510(k) Submission Details - K171402

510(k) Number K171402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2017
Decision Date February 02, 2018
Days to Decision 266 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 90d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EOB Device Classification - Class 2, Special Controls

Product Code EOB Nasopharyngoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4760
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EOB Nasopharyngoscope (flexible Or Rigid)

All 128
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K171402.
PENTAX Medical VIVIDEO ENT Videoscope Solution
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K172156 · Pentax Medical · Apr 2018
Medrobotics Flex Robotic System
K170453 · Medrobotics Corporation · Oct 2017
ShenDa Sinuscope
K161298 · Shenyang Shenda Endoscope Co., Ltd. · Aug 2017
AED Sinuscope
K170285 · National Advanced Endoscopy Devices, Inc. · Aug 2017