Cleared Traditional

K062441 - BARRX HALO COAGULATION SYSTEM

Also marketed or referenced as:
GENERATOR, MODEL 90-9000 OUTPUT CABLE, MODEL 90-9010 FOOTSWITCH, MODEL 90-9020

K062441 is an FDA 510(k) clearance for BARRX HALO COAGULATION SYSTEM, manufactured by Barrx Medical, Incorporated. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K062441 · Barrx Medical, Incorporated · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
85d
Days
Class 2
Risk

K062441 is an FDA 510(k) clearance for the BARRX HALO COAGULATION SYSTEM. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Barrx Medical, Incorporated (Washington, US). The FDA issued a Cleared decision on November 14, 2006 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.

FDA 510(k) Submission Details - K062441

510(k) Number K062441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2006
Decision Date November 14, 2006
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
Combination Product No
PCCP Authorized No
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.

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 2233
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K062441.
LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELECTRODE, MODELS LF5034 AND LF5044
K063195 · Valleylab · Nov 2006
SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL
K063161 · Leonhard Lang GmbH · Nov 2006
ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
K061829 · New Leaf Medical, Inc. · Nov 2006
HALO90 COAGULATION CATHETER
K062723 · Barrx Medical, Incorporated · Nov 2006
ELECTRODE COATED BALL, MODEL AB302C
K061878 · E Surgical, LLC · Oct 2006
ENSEAL PTC TISSUE SEATING SEALING DEVICE
K062949 · Surgrx, Inc. · Oct 2006
K062441 · BARRX HALO COAGULATION SYSTEM
Download PDF FDA Summary Barrx Medical, Incorp…