ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM
FDA 510(k) clearance K050411 · decided 2005-09-02
Clearance details
- K-number
- K050411
- Device name
- ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-02-17
- Decision date
- 2005-09-02
- Days to decision
- 197 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
- Dover, OH, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
| ACCUTEST (K940615) | Instrumed, Inc. | 1995-05-19 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S. 3200TS Tourniquet Systems Model recall (Z-1202-2026) | Zimmer Surgical Inc | 2026-01-28 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095) | Zimmer, Inc. | 2025-08-18 |
| NexGen© LPSFlex/LPS Mobile Bearing Knee System (P060037/S093) | Zimmer, Inc. | 2025-04-09 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094) | Zimmer, Inc. | 2025-04-01 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092) | Zimmer, Inc. | 2024-12-12 |
| NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091) | Zimmer, Inc. | 2024-07-05 |
| NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090) | Zimmer, Inc. | 2024-05-17 |
| NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089) | Zimmer, Inc. | 2024-04-04 |
| NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088) | Zimmer, Inc. | 2024-02-13 |