Zimmer A.T.S. 4000TS Automatic Tourniquet System
FDA 510(k) K123553 · Zimmer, Inc.
510(k) numberK123553
Submission
- Device name
- Zimmer A.T.S. 4000TS Automatic Tourniquet System
- Applicant
- Zimmer, Inc.
Indianpolis, IN, US - Received
- November 19, 2012
- Decision date
- August 9, 2013
- 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 |
| 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 |
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Questions and answers
When was Zimmer A.T.S. 4000TS Automatic Tourniquet System cleared by the FDA?
Zimmer A.T.S. 4000TS Automatic Tourniquet System (K123553) received a 510(k) decision of Substantially Equivalent on August 9, 2013, 263 days after the submission was received.
What is the product code of K123553?
The FDA product code is KCY – Tourniquet, Pneumatic, a Class I (low risk) device regulated under 21 CFR 878.5910.