Cleared Traditional

K191102 - Precision S 4K Sinuscope

K191102 is the FDA 510(k) clearance for Precision S 4K Sinuscope by Stryker. It is a Class 2 Ear, Nose, Throat device (product code EOB) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K191102 · Stryker · Ear, Nose, Throat device
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Sep 2019
Decision
134d
Days
Class 2
Risk

K191102 is an FDA 510(k) clearance for the Precision S 4K Sinuscope. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Stryker (San Jose, US). The FDA issued a Cleared decision on September 6, 2019 after a review of 134 days - within the typical 510(k) review window.

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.

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Submission Details

510(k) Number K191102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2019
Decision Date September 06, 2019
Days to Decision 134 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
45d slower than avg
Panel avg: 89d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 86
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K191102.
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K192090 · Karl Storz SE & CO. KG · Jan 2020
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PENTAX Medical ENT Video Imaging System
K183691 · Pentax of America, Inc. · Jun 2019
Ambu aScope 4 RhinoLaryngo Slim
K191080 · Ambu A/S · May 2019