Cleared Special

K102646 - SPIDER FLEX MONOPOLAR HOOK

K102646 is an FDA 510(k) clearance for SPIDER FLEX MONOPOLAR HOOK, manufactured by Transenterix, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Special 510(k) pathway after a 50-day FDA review.

K102646 · Transenterix, Inc. · General & Plastic Surgery device
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Nov 2010
Decision
50d
Days
Class 2
Risk

K102646 is an FDA 510(k) clearance for the SPIDER FLEX MONOPOLAR HOOK. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Transenterix, Inc. (Morrisville, US). The FDA issued a Cleared decision on November 3, 2010 after a review of 50 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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 Transenterix, Inc. devices

FDA 510(k) Submission Details - K102646

510(k) Number K102646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2010
Decision Date November 03, 2010
Days to Decision 50 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
65d faster than avg
Panel avg: 115d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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.

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