Cleared Traditional

K100390 - SURGIMAX/ SURGIMAX PLUS

K100390 is an FDA 510(k) clearance for SURGIMAX/ SURGIMAX PLUS, manufactured by Elliquence, LLC. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K100390 · Elliquence, LLC · General & Plastic Surgery device
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Aug 2010
Decision
190d
Days
Class 2
Risk

K100390 is an FDA 510(k) clearance for the SURGIMAX/ SURGIMAX PLUS. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Elliquence, LLC (Shelton, US). The FDA issued a Cleared decision on August 25, 2010 after a review of 190 days - an extended review 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: 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 Elliquence, LLC devices

FDA 510(k) Submission Details - K100390

510(k) Number K100390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2010
Decision Date August 25, 2010
Days to Decision 190 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
75d slower than avg
Panel avg: 115d · This submission: 190d
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 2080
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K100390.
OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB
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VASCUCLEAR PRECISION BIPOLAR
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AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015
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NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE'
K101967 · Ellman Int'L, Inc. · Aug 2010
ABLATION INSTRUMENT, MODEL 1635
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