Cleared Traditional

K162126 - Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW)

K162126 is an FDA 510(k) clearance for Ambient KVac Wand with Integrated Finge..., manufactured by ArthroCare Corporation. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K162126 · ArthroCare Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
59d
Days
Class 2
Risk

K162126 is an FDA 510(k) clearance for the Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac In.... Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by ArthroCare Corporation (Austin, US). The FDA issued a Cleared decision on September 29, 2016 after a review of 59 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all ArthroCare Corporation devices

FDA 510(k) Submission Details - K162126

510(k) Number K162126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2016
Decision Date September 29, 2016
Days to Decision 59 days
Submission Type Traditional
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
56d faster than avg
Panel avg: 115d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1748
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K162126.
Spetzler Malis Dual Illuminating Bipolar Forceps
K160103 · Synergetics · Oct 2016
PK Morcellator
K161038 · Gyrus Acmi, Inc. · Oct 2016
Viveve System
K162547 · Viveve, Inc. · Oct 2016
PK AIM
K161825 · Gyrus Acmi, Inc. · Sep 2016
Aerin Medical Stylus
K161994 · Aerin Medical, Inc. · Sep 2016
LigaSure Retractable L-Hook Laparoscopic Sealer/Divider
K161804 · Covidien · Sep 2016