Cleared Special

K052857 - ELECTROSURGICAL GENERATOR SYSTEM

K052857 is the FDA 510(k) clearance for ELECTROSURGICAL GENERATOR SYSTEM by Senorx, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Special 510(k) pathway after a 10-day FDA review.

K052857 · Senorx, Inc. · General & Plastic Surgery device
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Oct 2005
Decision
10d
Days
Class 2
Risk

K052857 is an FDA 510(k) clearance for the ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Senorx, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on October 21, 2005 after a review of 10 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 Senorx, Inc. devices

Submission Details

510(k) Number K052857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2005
Decision Date October 21, 2005
Days to Decision 10 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 115d · This submission: 10d
Pathway characteristics
Modification to existing cleared device.

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 K052857.
ATRICURE TRANSPOLAR SYSTEM
K052893 · AtriCure, Inc. · Oct 2005
ALUMA SKIN RENEWAL SYSTEM
K051214 · Lumenis, Inc. · Oct 2005
ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185
K052104 · Conmed Corporation · Oct 2005
CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MODELS 80-1163, 80-1189
K052449 · Codman & Shurtleff, Inc. · Oct 2005
STRYKER STILETTO ELECTROSURGICAL PROBE
K052141 · Stryker Endoscopy · Oct 2005
ARTHROCARE ARTHROWANDS
K052686 · Arthrocare Corp. · Oct 2005