Tourniquet Cuff; Pneumatic Tourniquet
FDA 510(k) K012632 · Medical Instruments Technology, Inc.
510(k) numberK012632
Submission
- Device name
- Tourniquet Cuff; Pneumatic Tourniquet
- Applicant
- Medical Instruments Technology, Inc.
St. George, UT, US - Received
- August 13, 2001
- Decision date
- October 26, 2001
- 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 |
| 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 |
| 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 |
|---|---|---|
| K012614 | Kendall, Sequential Compression Device; Huntleigh, Flowtron; Venaflow; Acufex; Alps…JOW · Traditional | 05/01/2002SE |
| K012640 | Electrosurgical Cutting and Coagulation Accessories, Electrosurgical WandsHRX · Traditional | 02/28/2002SE |
| K012624 | Reprocessed Arthroscopic Blades, Arthroscopic Shavers, Shaver Blade, Blade, Limited…HRX · Traditional | 11/08/2001SE |
| K884611 | The Orthoranger II Electronic GoniometerKQX · Traditional | 01/31/1989SE |
Questions and answers
When was Tourniquet Cuff; Pneumatic Tourniquet cleared by the FDA?
Tourniquet Cuff; Pneumatic Tourniquet (K012632) received a 510(k) decision of Substantially Equivalent on October 26, 2001, 74 days after the submission was received.
What is the product code of K012632?
The FDA product code is KCY – Tourniquet, Pneumatic, a Class I (low risk) device regulated under 21 CFR 878.5910.