FDA Product Code
FDA Product Code KCY — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.5910
510(k) Clearances — 34 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K202919 | ATS 5000 Automatic Tourniquet Instrument | Mcewen and Associates Consulting , Ltd. | 2021-05-20 | Traditional | PDF ↗ |
| K162365 | T-Cuff | Terumobct, Inc. | 2017-02-16 | Traditional | PDF ↗ |
| K123553 | ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM | Zimmer, Inc. | 2013-08-09 | Traditional | PDF ↗ |
| K112874 | EZ VEIN INFLATABLE TOURNIQUET | Dominion Medical Devices, LLC | 2011-10-17 | Traditional | PDF ↗ |
| K071140 | MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 | Top Spins, Inc. | 2007-06-07 | Traditional | PDF ↗ |
| K050411 | ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM | Zimmer, Inc. | 2005-09-02 | Traditional | PDF ↗ |
| K012632 | TOURNIQUET CUFF; PNEUMATIC TOURNIQUET | Medical Instruments Technology, Inc. | 2001-10-26 | Traditional | PDF ↗ |
| K955552 | EXPRESSAIRE TORUNIQUET SYSTEM | Smith & Nephew Richards, Inc. | 1996-01-05 | Traditional | PDF ↗ |
| K954201 | BUONAFEDE PNEUMATIC SLEEVE | Promedic, Inc. | 1995-11-09 | Traditional | PDF ↗ |
| K954103 | TOURNI-COMP | Scandinavian Medical JW AB | 1995-11-01 | Traditional | PDF ↗ |
| K953953 | DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF | Deroyal Industries, Inc. | 1995-09-29 | Traditional | PDF ↗ |
| K952038 | CLEAN-CUFF | Instrumed, Inc. | 1995-07-11 | Traditional | PDF ↗ |
| K940615 | ACCUTEST | Instrumed, Inc. | 1995-05-19 | Traditional | PDF ↗ |
| K945167 | DJ MEDICAL PNEUMATIC TOURNIQUET | Dj Medical, Inc. | 1995-02-13 | Traditional | PDF ↗ |
| K942303 | TECNADYNE T-CUFF | Technadyne Scientific, Inc. | 1994-07-20 | Traditional | PDF ↗ |
| K933994 | ARTHREX TOURNIQUET FOR LEG HOLDER | Arthrex, Inc. | 1994-03-23 | Traditional | PDF ↗ |
| K925033 | STILLE AUTOMATIC TOURNIQUET | Ferguson Medical | 1993-02-01 | Traditional | PDF ↗ |
| K924273 | ACCUFLATE | Instrumed, Inc. | 1993-01-12 | Traditional | PDF ↗ |
| K910449 | PRESTITCH | Crantec Co. | 1992-05-29 | Traditional | PDF ↗ |
| K910512 | ACCUFLATE | Instrumed, Inc. | 1991-02-19 | Traditional | PDF ↗ |
| K900104 | TCPM II TOURNIQUET CUFF PRESSURE MONITOR | Electromedics, Inc. | 1990-03-15 | Traditional | PDF ↗ |
| K890014 | DISPOSABLE COLOR-CUFFS | Instrumed, Inc. | 1989-01-24 | Traditional | PDF ↗ |
| K880020 | 3 IN 1 AUTOMATIC TOURNIQUET | Systematics Mfg. & Tool Co., Inc. | 1988-03-17 | Traditional | PDF ↗ |
| K871982 | TOURNIQUET PRESSURE REGULATOR | Avec Scientific Design Corp. | 1987-06-09 | Traditional | PDF ↗ |
| K870784 | A.T.S. 1500 TOURNIQUET | Aspen Laboratories, Inc. | 1987-03-18 | Traditional | PDF ↗ |
| K860463 | SINGLE AND DUAL TOURNIQUET CUFF | Aspen Laboratories, Inc. | 1986-02-25 | Traditional | PDF ↗ |
| K860095 | DIGIKIT NONPNEUMATIC TOURNIQUET | Orthofab, Inc. | 1986-01-24 | Traditional | PDF ↗ |
| K853802 | ATS 500 TOURNIQUET | Aspen Laboratories, Inc. | 1985-10-07 | Traditional | PDF ↗ |
| K842963 | RHYS-DAVIES EXSANGUINATOR | Woodville Polymer Engineering, Ltd. | 1984-08-17 | Traditional | PDF ↗ |
| K841558 | BANANA CUFF | Aspen Laboratories, Inc. | 1984-07-16 | Traditional | PDF ↗ |
| K840206 | PRESSURE SENTRY TOURNIQUET | Richards Medical Co., Inc. | 1984-04-25 | Traditional | PDF ↗ |
| K813231 | TOURNIQUET | Aspen Laboratories, Inc. | 1981-12-14 | Traditional | PDF ↗ |
| K791759 | TEST PRESSURE GAUGE #6675-32 | Depuy, Inc. | 1979-10-04 | Traditional | PDF ↗ |
| K780988 | DEVIN-NESTOR PNEUMATIC TOURNIQUET | Nestor Engineering Associates, Inc. | 1978-10-03 | Traditional | PDF ↗ |
Product code KCY · Class I · General, Plastic Surgery. Data: openFDA.