Cleared Special

K153679 - Stryker Neptune E-SEP Smoke Evacuation Pencil

K153679 is an FDA 510(k) clearance for Stryker Neptune E-SEP Smoke Evacuation ..., manufactured by Stryker Corporation. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 32-day FDA review.

K153679 · Stryker Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
32d
Days
Class 2
Risk

K153679 is an FDA 510(k) clearance for the Stryker Neptune E-SEP Smoke Evacuation Pencil. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on January 22, 2016 after a review of 32 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stryker Corporation devices

FDA 510(k) Submission Details - K153679

510(k) Number K153679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2015
Decision Date January 22, 2016
Days to Decision 32 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 115d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1404
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K153679.
THUNDERBEAT Open Fine Jaw
K151743 · Olympus Medical Systems Corp. · Feb 2016
Epix Electrosurgical Probe with Smoke Evacuation
K151480 · Applied Medical Resources · Feb 2016
InMode RF System
K151793 · Inmode MD , Ltd. · Feb 2016
Paragon T2 Wand with Integrated Cable
K153675 · ArthroCare Corporation · Jan 2016
New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated
K153265 · New Deantronics Taiwan , Ltd. · Jan 2016
InMode FRF Applicator
K151273 · Inmode MD , Ltd. · Jan 2016