Cleared Special

K102117 - TISSU TRANS FILTRON SYRINGE FILL
(FDA 510(k) Clearance)

K102117 · Shippert Medical Technologies Corp. · General & Plastic Surgery

Aug 2010

Decision

Days

Class 2

Risk

K102117 is an FDA 510(k) clearance for the TISSU TRANS FILTRON SYRINGE FILL, a System, Suction, Lipoplasty (Class II — Special Controls, product code MUU), submitted by Shippert Medical Technologies Corp. (Centennial, US). The FDA issued a Cleared decision on August 6, 2010, 9 days after receiving the submission on July 28, 2010. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5040.

Submission Details

510(k) Number	K102117 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	MUU — System, Suction, Lipoplasty
Device Class	Class II — 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).