Cleared Traditional

K013641 - SENORX BIOPSY DEVICE

K013641 is the FDA 510(k) clearance for SENORX BIOPSY DEVICE by Senorx, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K013641 · Senorx, Inc. · General & Plastic Surgery device
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Jan 2002
Decision
85d
Days
Class 2
Risk

K013641 is an FDA 510(k) clearance for the SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CO.... 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 January 29, 2002 after a review of 85 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 Senorx, Inc. devices

Submission Details

510(k) Number K013641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2001
Decision Date January 29, 2002
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
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 1130
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K013641.
NELSON ELECTROSURGICAL UNIT, MODEL GN640
K014172 · Aesculap, Inc. · Mar 2002
AARON REUSABLE ELECTROSURGICAL ELECTRODE
K014201 · Aaron Medical Industries · Feb 2002
DYONICS ELECTROBLADE RESECTOR
K012314 · Smith & Nephew, Inc. · Feb 2002
ARTHROCARE CONTROLLER, PATIENT CABLE, FOOT CONTROL, POWER CORD
K014222 · Arthrocare Corp. · Jan 2002
INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY
K013416 · Intuitive Surgical, Inc. · Jan 2002
REPROCESSED SOFT TISSUE ABLATORS
K012631 · Alliance Medical Corp. · Dec 2001