EXPRESSAIRE TORUNIQUET SYSTEM
FDA 510(k) clearance K955552 · decided 1996-01-05
Clearance details
- K-number
- K955552
- Device name
- EXPRESSAIRE TORUNIQUET SYSTEM
- Applicant
- Smith & Nephew Richards, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-12-05
- Decision date
- 1996-01-05
- Days to decision
- 31 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
- Bartlett, TN, US
- Third-party review
- No
- Expedited review
- No
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| T-Cuff (K162365) | Terumobct, Inc. | 2017-02-16 |
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| 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 |
| 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 |
| ACCUTEST (K940615) | Instrumed, Inc. | 1995-05-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OSTEOPAL (P810020/S005) | Smith & Nephew Richards, Inc. | 1998-10-15 |
| PALACOS E-FLOW (OSTEOPAL) BONE CEMENT (P810020/S004) | Smith & Nephew Richards, Inc. | 1998-07-30 |
| PALACOS R BONE CEMENT (P810020/S003) | Smith & Nephew Richards, Inc. | 1992-02-14 |
| PALACOS R BONE CEMENT (P810020/S002) | Smith & Nephew Richards, Inc. | 1989-01-30 |
| PALACOS R BONE CEMENT (P810020/S001) | Smith & Nephew Richards, Inc. | 1984-08-14 |
| PALACOS R BONE CEMENT (P810020) | Smith & Nephew Richards, Inc. | 1984-02-02 |