510(k) K092482

TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500 by Shippert Medical Technologies Corp. — Product Code MUU

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 4, 2009
Date Received: August 13, 2009
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Suction, Lipoplasty
Device Class: Class II
Regulation Number: 878.5040
Review Panel: SU
Submission Type

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).

Other clearances by Shippert Medical Technologies Corp.

K102117 — TISSU TRANS FILTRON SYRINGE FILL (August 6, 2010)
K092022 — TISSU TRANS HARVEST TUBING (August 17, 2009)
K050797 — TISSU-TRANS (July 13, 2005)
K964855 — EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD (March 4, 1997)
K964334 — EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT) (December 9, 1996)
K963704 — MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE (November 26, 1996)
K962133 — EXPANDACELL INJECTO-PAK (August 1, 1996)
K960621 — EXPANDACELL INSTRUMENT WIPE (April 1, 1996)
K960228 — EXPANDACELL INJECTO-PAK NASAL PACK (February 27, 1996)
K955593 — EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAY (December 22, 1995)

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K193539 — REVOLVE ENVI 600 Advanced Adipose System (May 28, 2020)
K193363 — Dermapose Refresh (April 14, 2020)
K182732 — JTL-250-01 (November 18, 2019)
K191564 — Progenikine Concentrating System 25 mL System (November 7, 2019)
K190386 — KTA Adipose Treatment Kit (October 10, 2019)
K190278 — AuraGen 123 Suction Lipoplasty System (A123) (May 3, 2019)
K172717 — Automatic Tissue Processing Unit (May 25, 2018)