KCY — Tourniquet, Pneumatic Class I
FDA product code KCY covers "Tourniquet, Pneumatic", a Class I medical device regulated under 21 CFR 878.5910. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KCY
- Device Class
- Class I
- Regulation Number
- 878.5910
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K202919 | mcewen and associates consulting | ATS 5000 Automatic Tourniquet Instrument | May 20, 2021 |
| K162365 | terumobct | T-Cuff | February 16, 2017 |
| K123553 | zimmer | ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM | August 9, 2013 |
| K112874 | dominion medical devices | EZ VEIN INFLATABLE TOURNIQUET | October 17, 2011 |
| K071140 | top spins | MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 | June 7, 2007 |
| K050411 | zimmer | ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM | September 2, 2005 |
| K012632 | medical instruments technology | TOURNIQUET CUFF; PNEUMATIC TOURNIQUET | October 26, 2001 |
| K955552 | smith and nephew richards | EXPRESSAIRE TORUNIQUET SYSTEM | January 5, 1996 |
| K954201 | promedic | BUONAFEDE PNEUMATIC SLEEVE | November 9, 1995 |
| K954103 | scandinavian medical jw | TOURNI-COMP | November 1, 1995 |
| K953953 | deroyal industries | DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF | September 29, 1995 |
| K952038 | instrumed | CLEAN-CUFF | July 11, 1995 |
| K940615 | instrumed | ACCUTEST | May 19, 1995 |
| K945167 | dj medical | DJ MEDICAL PNEUMATIC TOURNIQUET | February 13, 1995 |
| K942303 | technadyne scientific | TECNADYNE T-CUFF | July 20, 1994 |
| K933994 | arthrex | ARTHREX TOURNIQUET FOR LEG HOLDER | March 23, 1994 |
| K925033 | ferguson medical | STILLE AUTOMATIC TOURNIQUET | February 1, 1993 |
| K924273 | instrumed | ACCUFLATE | January 12, 1993 |
| K910449 | crantec | PRESTITCH | May 29, 1992 |
| K910512 | instrumed | ACCUFLATE | February 19, 1991 |