Tissu Trans Filtron, Models 3-TT-FILTRON 2000-500
FDA 510(k) K092482 · Shippert Medical Technologies Corp.
510(k) numberK092482
Submission
- Device name
- Tissu Trans Filtron, Models 3-TT-FILTRON 2000-500
- Applicant
- Shippert Medical Technologies Corp.
Centennial, CO, US - Received
- August 13, 2009
- Decision date
- December 4, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MUU – System, Suction, Lipoplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5040
- Specialty
- General, Plastic Surgery
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).
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| 510(k) | Device | Decision |
|---|---|---|
| K102117 | Tissu Trans Filtron Syringe FillMUU · Special | 08/06/2010SE |
| K092022 | Tissu Trans Harvest TubingKYZ · Special | 08/17/2009SE |
| K050797 | Tissu-TransKYZ · Traditional | 07/13/2005SE |
| K964855 | Expandacell Eye Spear, Eye Wick, Wick Drain and Corneal ShieldHOZ · Traditional | 03/04/1997SE |
| K964334 | Expandacell Anti-Fog Instrument Wipe (with Alcohol)/(Without)GCJ · Traditional | 12/09/1996SE |
| K963704 | Muscle Wand, a Device for Deep Pressure Muscle MassageLYG · Traditional | 11/26/1996SE |
| K962133 | Expandacell Injecto-PakEMX · Traditional | 08/01/1996SE |
| K960621 | Expandacell Instrument WipeGEC · Traditional | 04/01/1996SE |
| K960228 | Expandacell Injecto-Pak Nasal PackEMX · Traditional | 02/27/1996SE |
| K955593 | Expandacell Anatomical Posterior Nasal Pack W/& Without AirwayEMX · Traditional | 12/22/1995SE |
Questions and answers
When was Tissu Trans Filtron, Models 3-TT-FILTRON 2000-500 cleared by the FDA?
Tissu Trans Filtron, Models 3-TT-FILTRON 2000-500 (K092482) received a 510(k) decision of Substantially Equivalent on December 4, 2009, 113 days after the submission was received.
What is the product code of K092482?
The FDA product code is MUU – System, Suction, Lipoplasty, a Class II (moderate risk) device regulated under 21 CFR 878.5040.