Cleared Special

K050361 - MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE

K050361 is an FDA 510(k) clearance for MODIFICATION TO CONCERTO BIPOLAR NEEDLE..., manufactured by Boston Scientific Corp. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 28-day FDA review.

K050361 · Boston Scientific Corp · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
28d
Days
Class 2
Risk

K050361 is an FDA 510(k) clearance for the MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on March 14, 2005 after a review of 28 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 Boston Scientific Corp devices

FDA 510(k) Submission Details - K050361

510(k) Number K050361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2005
Decision Date March 14, 2005
Days to Decision 28 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
87d faster than avg
Panel avg: 115d · This submission: 28d
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 1743
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K050361.
ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM
K050671 · Surgrx, Inc. · Apr 2005
NEOTHERMIA EN-BLOC BIOPSY SYSTEM
K050737 · Neothermia Corporation · Mar 2005
MEGA POWER ELECTROSURGICAL GENERATOR
K050579 · Megadyne Medical Products, Inc. · Mar 2005
MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM
K050364 · Valley Forge Scientific Corp. · Mar 2005
GYRUS PLASMA SKIN RESURFACING SYSTEM
K041999 · Gyrus Medical, Inc. · Mar 2005
VIVAWAVE MICROWAVE ABLATION SYSTEM, COAXIAL INTRODUCER
K050223 · Vivant Medical, Inc. · Feb 2005