Cleared Traditional

K191280 - E-100 Electrosurgical Generator

K191280 is the FDA 510(k) clearance for E-100 Electrosurgical Generator by Intuitive Surgical, Inc.. It is a Class 2 General & Plastic Surgery device (product code NAY) cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K191280 · Intuitive Surgical, Inc. · General & Plastic Surgery device
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Nov 2019
Decision
185d
Days
Class 2
Risk

K191280 is an FDA 510(k) clearance for the E-100 Electrosurgical Generator, SynchroSeal. Classified as System, Surgical, Computer Controlled Instrument (product code NAY), Class II - Special Controls.

Submitted by Intuitive Surgical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 14, 2019 after a review of 185 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Intuitive Surgical, Inc. devices

Submission Details

510(k) Number K191280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2019
Decision Date November 14, 2019
Days to Decision 185 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
70d slower than avg
Panel avg: 115d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NAY System, Surgical, Computer Controlled Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - NAY System, Surgical, Computer Controlled Instrument

All 159
Devices cleared under the same product code (NAY) and FDA review panel - the closest regulatory comparables to K191280.
Senhance Surgical System
K200049 · Transenterix, Inc. · Mar 2020
da Vinci Xi Surgical System, da Vinci X Surgical System
K191529 · Intuitive Surgical · Feb 2020
Senhance Surgical System
K192877 · Transenterix, Inc. · Nov 2019
da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30
K191736 · Intuitive Surgical · Jul 2019
SureForm 45 Curved Tip, SureForm 45 Gray Reload
K190999 · Intuitive Surgical, Inc. · Jul 2019
Senhance Surgical System
K191482 · Transenterix, Inc. · Jul 2019