TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500— 510(k) K092482

Name: FDA 510(k) clearance K092482
Creator: U.S. Food and Drug Administration
Published: 2009-12-04

Substantially Equivalent

Shippert Medical Technologies Corp.

FDA 510(k) clearance K092482 for TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500, Substantially Equivalent on 2009-12-04. Applicant: Shippert Medical Technologies Corp.. Device class: 2.

Clearance details

Applicant: Shippert Medical Technologies Corp.
Product code: Code MUU
Device class: Class 2
Regulation: 21 CFR 878.5040
Advisory panel: General, Plastic Surgery
Date received: 2009-08-13
Decision date: 2009-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Centennial, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MUU

view all

K210528 — IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit2022-03-16
K203800 — SyntrFuge System2021-07-02
K202443 — Smart Kit Basic, Smart Kit Pro2021-03-11
K193539 — REVOLVE ENVI 600 Advanced Adipose System2020-05-28
K193363 — Dermapose Refresh2020-04-14

More clearances from Shippert Medical Technologies Corp.

view all

K102117 — TISSU TRANS FILTRON SYRINGE FILL2010-08-06
K092022 — TISSU TRANS HARVEST TUBING2009-08-17
K050797 — TISSU-TRANS2005-07-13
K964855 — EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD1997-03-04
K964334 — EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT)1996-12-09

Recalls naming K092482

K-number listed on FDA's recall record

Z-1330-2019 — Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.Class II·Completed·Shippert Medical Technologies·20180202
Z-1331-2019 — Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.Class II·Completed·Shippert Medical Technologies·20180202
Z-1332-2019 — Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.Class II·Completed·Shippert Medical Technologies·20180202
Z-1333-2019 — Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.Class II·Completed·Shippert Medical Technologies·20180202
Z-1334-2019 — Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.Class II·Completed·Shippert Medical Technologies·20180202
Z-1335-2019 — Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.Class II·Completed·Shippert Medical Technologies·20180202
Z-1336-2019 — Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.Class II·Completed·Shippert Medical Technologies·20180202
Z-0170-2018 — Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction.Class II·Terminated·Shippert Medical Technologies·20171020

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092482.

Data sourced from openFDA. This site is unofficial and independent of the FDA.