Arthrex Tourniquet for Leg Holder
FDA 510(k) K933994 · Arthrex, Inc.
510(k) numberK933994
Submission
- Device name
- Arthrex Tourniquet for Leg Holder
- Applicant
- Arthrex, Inc.
Naples, FL, US - Received
- August 17, 1993
- Decision date
- March 23, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
|---|---|---|
| K262451 | Arthrex DynaNite StaplesJDR · Traditional | 09/01/2026SE |
| K262357 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Special | 08/07/2026SE |
| K260624 | Arthrex Radial Head Replacement SystemKWI · Traditional | 07/30/2026SE |
| K260018 | Arthrex FiberButtonMBI · Traditional | 06/26/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | 06/25/2026SE |
| K253931 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Traditional | 05/28/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | 05/08/2026SE |
| K260561 | Arthrex FiberTak Suture AnchorMBI · Special | 03/20/2026SE |
| K252016 | Arthrex Humeral NailsHSB · Traditional | 03/20/2026SE |
| K260405 | FiberTape ButtonMBI · Special | 03/09/2026SE |
Questions and answers
When was Arthrex Tourniquet for Leg Holder cleared by the FDA?
Arthrex Tourniquet for Leg Holder (K933994) received a 510(k) decision of Substantially Equivalent on March 23, 1994, 218 days after the submission was received.
What is the product code of K933994?
The FDA product code is KCY – Tourniquet, Pneumatic, a Class I (low risk) device regulated under 21 CFR 878.5910.