T-Cuff
FDA 510(k) K162365 · Terumobct, Inc.
510(k) numberK162365
Submission
- Device name
- T-Cuff
- Applicant
- Terumobct, Inc.
Lakewood, CO, US - Received
- August 23, 2016
- Decision date
- February 16, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KCY – Tourniquet, Pneumatic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.5910
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KCY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K202919 | ATS 5000 Automatic Tourniquet InstrumentKCY · Traditional | Mcewen and Associates Consulting , Ltd. | 05/20/2021SE |
| K123553 | Zimmer A.T.S. 4000TS Automatic Tourniquet SystemKCY · Traditional | Zimmer, Inc. | 08/09/2013SE |
| K112874 | Ez Vein Inflatable TourniquetKCY · Traditional | Dominion Medical Devices, LLC | 10/17/2011SE |
| K071140 | MRI Compatible Thigh Tourniquet, Model C070002KCY · Traditional | Top Spins, Inc. | 06/07/2007SE |
| K050411 | Zimmer A.T.S. 3000 Automatic Tourniquet SystemKCY · Traditional | Zimmer, Inc. | 09/02/2005SE |
| K012632 | Tourniquet Cuff; Pneumatic TourniquetKCY · Traditional | Medical Instruments Technology, Inc. | 10/26/2001SE |
| K955552 | Expressaire Toruniquet SystemKCY · Traditional | Smith & Nephew Richards, Inc. | 01/05/1996SE |
| K954201 | Buonafede Pneumatic SleeveKCY · Traditional | Promedic, Inc. | 11/09/1995SE |
| K954103 | Tourni-CompKCY · Traditional | Scandinavian Medical JW AB | 11/01/1995SE |
| K953953 | Deroyal Industries, Inc. Pneumatic Tourniquet CuffKCY · Traditional | Deroyal Industries, Inc. | 09/29/1995SE |
More from Deroyal Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K183081 | Spectra Optia Apheresis SystemLKN · Traditional | 02/05/2019SE |
| K181049 | Spectra Optia Apheresis SystemLKN · Special | 11/01/2018SE |
| K172590 | Spectra Optia Apheresis SystemLKN · Traditional | 03/02/2018SE |
| K153601 | Spectra Optia Apheresis SystemLKN · Special | 01/14/2016SE |
| K141938 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood Tubing Set)LKN · Traditional | 03/23/2015SE |
| K132429 | Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange…LKN · Traditional | 12/06/2013SE |
| K131744 | Spectra Optia Apheresis System, Spectra Optia Single-Needle Connector, Spectra Optia…LKN · Traditional | 08/08/2013SE |
Questions and answers
When was T-Cuff cleared by the FDA?
T-Cuff (K162365) received a 510(k) decision of Substantially Equivalent on February 16, 2017, 177 days after the submission was received.
What is the product code of K162365?
The FDA product code is KCY – Tourniquet, Pneumatic, a Class I (low risk) device regulated under 21 CFR 878.5910.