Cleared Special

K062723 - HALO90 COAGULATION CATHETER

K062723 is an FDA 510(k) clearance for HALO90 COAGULATION CATHETER, manufactured by Barrx Medical, Incorporated. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 58-day FDA review.

K062723 · Barrx Medical, Incorporated · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
58d
Days
Class 2
Risk

K062723 is an FDA 510(k) clearance for the HALO90 COAGULATION CATHETER. 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 (Sunnyvale, US). The FDA issued a Cleared decision on November 9, 2006 after a review of 58 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 Barrx Medical, Incorporated devices

FDA 510(k) Submission Details - K062723

510(k) Number K062723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2006
Decision Date November 09, 2006
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Modification to existing cleared device.

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 1492
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K062723.
LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420,
K063025 · Lina Medical Aps · Dec 2006
ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD AND WANDS
K063538 · Arthrocare Corp. · Dec 2006
SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL
K063161 · Leonhard Lang GmbH · Nov 2006
THERMASSAGE
K061001 · Thermage, Inc. · Oct 2006
STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLE
K061660 · Stryker Instruments · Oct 2006
ADAPTABLE MONOPOLAR ADAPTABLE AND/OR RETRACTABLE ELECTRODES
K062047 · PAJUNK GmbH Medizintechnologie · Oct 2006