Cleared Special

GIBBONS STERILE TROCAR KITS (K012198) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K012198 · Gibbons Surgical Corp. · General & Plastic Surgery device
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Aug 2001
Decision
27d
Days
Class 2
Risk

K012198 is an FDA 510(k) clearance for the GIBBONS STERILE TROCAR KITS. Classified as Trocar, Gastro-urology (product code FBQ), Class II - Special Controls.

Submitted by Gibbons Surgical Corp. (Virginia Beach, US). The FDA issued a Cleared decision on August 9, 2001 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.5090 - 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 Gibbons Surgical Corp. devices

Submission Details

510(k) Number K012198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2001
Decision Date August 09, 2001
Days to Decision 27 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FBQ Trocar, Gastro-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5090
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.