Cleared Special

K093203 - CARDIOBLATE BIPOLAR RADIOFREQUENCY SURG...

K093203 is the FDA 510(k) clearance for CARDIOBLATE BIPOLAR RADIOFREQUENCY SURG... by Medtronic, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Special 510(k) pathway after a 136-day FDA review.

K093203 · Medtronic, Inc. · General & Plastic Surgery device
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Feb 2010
Decision
136d
Days
Class 2
Risk

K093203 is an FDA 510(k) clearance for the CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60.... 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, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 26, 2010 after a review of 136 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic, Inc. devices

Submission Details

510(k) Number K093203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2009
Decision Date February 26, 2010
Days to Decision 136 days
Submission Type Special
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
21d slower than avg
Panel avg: 115d · This submission: 136d
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 1041
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