Single and Dual Tourniquet Cuff
FDA 510(k) K860463 · Aspen Laboratories, Inc.
510(k) numberK860463
Submission
- Device name
- Single and Dual Tourniquet Cuff
- Applicant
- Aspen Laboratories, Inc.
Englewood, CO, US - Received
- February 6, 1986
- Decision date
- February 25, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K162365 | T-CuffKCY · Traditional | Terumobct, Inc. | 02/16/2017SE |
| 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 |
More from Scandinavian Medical JW AB
| 510(k) | Device | Decision |
|---|---|---|
| K981220 | System 7500 Abc Electrosurgical UnitGEI · Traditional | 04/21/1998SE |
| K963088 | Sheath, Electrosurgical PencilGEI · Traditional | 09/13/1996SE |
| K955834 | System 6500 Abc Electrosurgical UnitGEI · Traditional | 07/11/1996SE |
| K960296 | 4000 EtmGEI · Traditional | 02/20/1996SE |
| K953081 | Beamer PlusGEI · Traditional | 10/30/1995SE |
| K953007 | Excalibur Plus Electrosurgical UnitGEI · Traditional | 08/21/1995SE |
| K946104 | Smokievac Electrosurgical PencilGEI · Traditional | 04/03/1995SE |
| K944012 | Electrosurgical Flexible Electrode In-Line Suction CoagulatorGEI · Traditional | 12/21/1994SE |
| K924960 | Excalibur Electrosurgical UnitGEI · Traditional | 04/16/1993SE |
| K913213 | Single Use Lee ElectrodeHGI · Traditional | 02/13/1992SE |
Questions and answers
When was Single and Dual Tourniquet Cuff cleared by the FDA?
Single and Dual Tourniquet Cuff (K860463) received a 510(k) decision of Substantially Equivalent on February 25, 1986, 19 days after the submission was received.
What is the product code of K860463?
The FDA product code is KCY – Tourniquet, Pneumatic, a Class I (low risk) device regulated under 21 CFR 878.5910.