Cleared Traditional

K170610 - PlasmaBlade T

K170610 is the FDA 510(k) clearance for PlasmaBlade T by Medtronic Advanced Energy. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K170610 · Medtronic Advanced Energy · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
43d
Days
Class 2
Risk

K170610 is an FDA 510(k) clearance for the PlasmaBlade T. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Medtronic Advanced Energy (Portsmouth, US). The FDA issued a Cleared decision on April 13, 2017 after a review of 43 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 Medtronic Advanced Energy devices

Submission Details

510(k) Number K170610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2017
Decision Date April 13, 2017
Days to Decision 43 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 1119
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K170610.
PK AIM
K170908 · Gyrus Acmi, Inc. · May 2017
LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated
K170869 · Covidien · Apr 2017
SlimShape System
K163415 · Syneron Medical, Ltd. · Apr 2017
Valleylab FT10 Electrosurgical Platform
K170170 · Covidien, LLC · Feb 2017
ENSEAL X1 Large Jaw Tissue Sealer
K163548 · Ethicon Endo-Surgery, LLC · Feb 2017
Barrx Anorectal RFA Wand
K162802 · Covidien, LLC · Jan 2017