510(k) K880020
- Device
- 3 In 1 Automatic Tourniquet
- Applicant
- SYSTEMATICS MFG. & TOOL CO., INC.
- 510(k) number
- K880020
- Product code
- KCY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-03-17
- Date received
- 1988-01-05
- Regulation
- 878.5910
- Classification name
- Tourniquet, Pneumatic
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- GUNTER BARTZ
- Address
- 1555-F Ocean Ave. Bohemia NY US 11716 11716
FDA Registration Numbers#
- 3008264111
- 3006703573
- 1423537
- 3014126909
- 2528981
- 3014739961
- 1526350
- 3011642792
- 3006535925
- 3013783488
- 3031887985
- 3013730933
- 3023228837
- 9613910
- 3007997036
- 3002907620
- 3010759902
- 3034520
- 2011171
- 9680579
- 1048735
- 3010123014
- 3016764932
- 3016445580
- 1018470
- 9611559
- 3031700059
- 1818910
- 3006975482
- 9680215
- 9681444
- 3015280549
- 3010273872
- 1921846
- 3004116008
- 3006128321
- 3009039068
- 3010883047
- 1649518
- 3033511104
- 1822565
- 1528668
- 3005698350
- 3025434447
- 1650907
- 3010291427
- 8040278
- 1722028
- 3015967359
- 8010482
- 3012276218
- 3010595915
- 3016678045
- 3015207155
- 3004905643
- 3016965559
- 3030733800
- 2320762
- 1043214
- 3033589330
- 3011277660
- 9611283
- 3030153385
- 8010939
- 2648666
- 2184171
- 3004727093
- 3014023545
- 3015225571
- 3004824601
- 3012494290
- 2032098
- 3003244954
- 1720929
- 2650143
- 3008381116
- 3005621729
- 1058584
- 3014830562
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KCY#
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|---|---|---|---|
| K202919 | ATS 5000 Automatic Tourniquet Instrument | Mcewen and Associates Consulting , Ltd. | 2021-05-20 |
| K162365 | T-Cuff | Terumobct, Inc. | 2017-02-16 |
| K123553 | ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM | Zimmer, Inc. | 2013-08-09 |
| K112874 | EZ VEIN INFLATABLE TOURNIQUET | Dominion Medical Devices, LLC | 2011-10-17 |
| K071140 | MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 | Top Spins, Inc. | 2007-06-07 |
| K050411 | ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM | Zimmer, Inc. | 2005-09-02 |
| K012632 | TOURNIQUET CUFF; PNEUMATIC TOURNIQUET | Medical Instruments Technology, Inc. | 2001-10-26 |
| K955552 | EXPRESSAIRE TORUNIQUET SYSTEM | Smith & Nephew Richards, Inc. | 1996-01-05 |
| K954201 | BUONAFEDE PNEUMATIC SLEEVE | Promedic, Inc. | 1995-11-09 |
| K954103 | TOURNI-COMP | Scandinavian Medical JW AB | 1995-11-01 |
| K953953 | DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF | Deroyal Industries, Inc. | 1995-09-29 |
| K952038 | CLEAN-CUFF | Instrumed, Inc. | 1995-07-11 |
| K940615 | ACCUTEST | Instrumed, Inc. | 1995-05-19 |
| K945167 | DJ MEDICAL PNEUMATIC TOURNIQUET | Dj Medical, Inc. | 1995-02-13 |
| K942303 | TECNADYNE T-CUFF | Technadyne Scientific, Inc. | 1994-07-20 |