Tissu Trans Harvest Tubing
FDA 510(k) K092022 · Shippert Medical Technologies Corp.
510(k) numberK092022
Submission
- Device name
- Tissu Trans Harvest Tubing
- Applicant
- Shippert Medical Technologies Corp.
Centennial, CO, US - Received
- July 6, 2009
- Decision date
- August 17, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KYZ – Syringe, Irrigating (Non Dental)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6960
- Specialty
- General Hospital
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| K201877 | OtoSet- Ear Cleaning SystemKYZ · Traditional | Safkan, Inc. | 11/05/2020SE |
| K102563 | Single Cannula Extended ApplicatorKYZ · Traditional | Micromedics, Inc. | 03/15/2011SE |
| K050797 | Tissu-TransKYZ · Traditional | Shippert Medical Technologies Corp. | 07/13/2005SE |
| K991254 | QS Delivery SystemKYZ · Traditional | Sub-Q, Inc. | 08/23/1999SE |
| K982435 | Irrigation Syringe KitKYZ · Traditional | Sub-Q, Inc. | 11/06/1998SE |
| K974288 | Zerowet SplashieldKYZ · Traditional | Zerowet, Inc. | 01/29/1998SE |
| K964833 | Rmi Dual Fluid Irrigating SyringeKYZ · Traditional | Research Medical, Inc. | 02/19/1997SE |
| K960725 | Marpp Pressure Monitoring SystemKYZ · Traditional | Paradigm Medical, Inc. | 07/15/1996SE |
| K960212 | CPR Irrigation TrayKYZ · Traditional | Custom Pack Reliability | 04/01/1996SE |
| K952407 | Redi Nurse System (RNS) Pre-Filled 10CC, 30CC, 60CC Syringe W/Sterile WaterKYZ · Traditional | Contour Fabricators of Florida, Inc. | 08/07/1995SE |
More from Contour Fabricators of Florida, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K102117 | Tissu Trans Filtron Syringe FillMUU · Special | 08/06/2010SE |
| K092482 | Tissu Trans Filtron, Models 3-TT-FILTRON 2000-500MUU · Traditional | 12/04/2009SE |
| 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 Harvest Tubing cleared by the FDA?
Tissu Trans Harvest Tubing (K092022) received a 510(k) decision of Substantially Equivalent on August 17, 2009, 42 days after the submission was received.
What is the product code of K092022?
The FDA product code is KYZ – Syringe, Irrigating (Non Dental), a Class I (low risk) device regulated under 21 CFR 880.6960.