TOURNIQUET
FDA 510(k) clearance K813231 · decided 1981-12-14
Clearance details
- K-number
- K813231
- Device name
- TOURNIQUET
- Applicant
- Aspen Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-11-17
- Decision date
- 1981-12-14
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- KCY
- Device class
- 1
- Regulation number
- 878.5910
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ATS 5000 Automatic Tourniquet Instrument (K202919) | Mcewen and Associates Consulting , Ltd. | 2021-05-20 |
| T-Cuff (K162365) | Terumobct, Inc. | 2017-02-16 |
| ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM (K123553) | Zimmer, Inc. | 2013-08-09 |
| EZ VEIN INFLATABLE TOURNIQUET (K112874) | Dominion Medical Devices, LLC | 2011-10-17 |
| MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 (K071140) | Top Spins, Inc. | 2007-06-07 |
| ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM (K050411) | Zimmer, Inc. | 2005-09-02 |
| TOURNIQUET CUFF; PNEUMATIC TOURNIQUET (K012632) | Medical Instruments Technology, Inc. | 2001-10-26 |
| EXPRESSAIRE TORUNIQUET SYSTEM (K955552) | Smith & Nephew Richards, Inc. | 1996-01-05 |
| BUONAFEDE PNEUMATIC SLEEVE (K954201) | Promedic, Inc. | 1995-11-09 |
| TOURNI-COMP (K954103) | Scandinavian Medical JW AB | 1995-11-01 |
| DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF (K953953) | Deroyal Industries, Inc. | 1995-09-29 |
| CLEAN-CUFF (K952038) | Instrumed, Inc. | 1995-07-11 |
Recalls involving this device
No recalls on record reference this clearance.