Cleared Special

K041981 - GUIDANT VASOVIEW 6 HARVESTING CANNULA

Also marketed or referenced as:
GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004

K041981 is an FDA 510(k) clearance for GUIDANT VASOVIEW 6 HARVESTING CANNULA, manufactured by Guidant Corporation. 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.

K041981 · Guidant Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
28d
Days
Class 2
Risk

K041981 is an FDA 510(k) clearance for the GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Guidant Corporation (Santa Clara, US). The FDA issued a Cleared decision on August 20, 2004 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 Guidant Corporation devices

FDA 510(k) Submission Details - K041981

510(k) Number K041981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2004
Decision Date August 20, 2004
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
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 1204
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K041981.
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VALUPEN,PROFILE
K041868 · Conmed Corporation · Sep 2004
SENORX INTRODUCER
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K040699 · Megadyne Medical Products, Inc. · Jun 2004