Cleared Special

K102117 - TISSU TRANS FILTRON SYRINGE FILL

K102117 is an FDA 510(k) clearance for TISSU TRANS FILTRON SYRINGE FILL, manufactured by Shippert Medical Technologies Corp.. The device is a Class 2 General & Plastic Surgery device with product code MUU cleared through the Special 510(k) pathway after a 9-day FDA review.

K102117 · Shippert Medical Technologies Corp. · General & Plastic Surgery device
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Aug 2010
Decision
9d
Days
Class 2
Risk

K102117 is an FDA 510(k) clearance for the TISSU TRANS FILTRON SYRINGE FILL. Classified as System, Suction, Lipoplasty (product code MUU), Class II - Special Controls.

Submitted by Shippert Medical Technologies Corp. (Centennial, US). The FDA issued a Cleared decision on August 6, 2010 after a review of 9 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5040 - 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 Shippert Medical Technologies Corp. devices

FDA 510(k) Submission Details - K102117

510(k) Number K102117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2010
Decision Date August 06, 2010
Days to Decision 9 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
106d faster than avg
Panel avg: 115d · This submission: 9d
Pathway characteristics
Modification to existing cleared device.

MUU Device Classification - Class 2, Special Controls

Product Code MUU System, Suction, Lipoplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5040
Definition See Federal Register Notice At 86 Fr 50887 “consolidation Of Devices That Process Autologous Human Cells, Tissues, And Cellular And Tissue-based Products At The Point Of Care To Produce A Therapeutic Article” (frn) (fda-2021-n-0881).
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.