COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM
FDA 510(k) clearance K910377 · decided 1991-04-19
Clearance details
- K-number
- K910377
- Device name
- COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM
- Applicant
- CooperSurgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-01-29
- Decision date
- 1991-04-19
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- GCX
- Device class
- 2
- Regulation number
- 880.6740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mountain View, CA, 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 |
|---|---|---|
| STRYKER CASSETTE PUMP (K042454) | Stryker Endoscopy | 2004-12-09 |
| CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (K992126) | Circon Corp. | 1999-08-03 |
| SUCTION INSTRUMENTATION (K972074) | Walter Lorenz Surgical, Inc. | 1997-07-25 |
| CHASE SUCKER (K971022) | Chase Medical, Inc. | 1997-04-17 |
| MEDI-VAC FLEXI-CLEAR SUCTION HANDLE (K964127) | Allegiance Healthcare Corp. | 1996-12-31 |
| CURITY THORACENTESIS TRAY (K964519) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1996-12-20 |
| STRYKER SUCTION REGULATOR (K963648) | Stryker Endoscopy | 1996-11-26 |
| RENTON SUCTION DEVICE U.S. PATENT*4,767,404 (K962920) | R&S Surgical, LLC | 1996-10-21 |
| MEDCARE SUCTION CONNECTING TUBING (K961880) | Medcare Medical Group, Inc. | 1996-07-19 |
| CPR YANKAUER (K960223) | Custom Pack Reliability | 1996-03-28 |
| MEDCARE YANKAUER SUCTION DEVICE (K954869) | Medcare Custom Packaging, Inc. | 1996-01-19 |
| STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) (K954726) | Stryker Endoscopy | 1995-11-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Mara Water Vapor Ablation System (P160047/S039) | CooperSurgical, Inc. | 2025-01-07 |
| MARA Water Vapor Ablation System (P160047/S035) | CooperSurgical, Inc. | 2024-07-11 |
| MARA Water Vapor Ablation System (P160047/S038) | CooperSurgical, Inc. | 2024-07-09 |
| MARA Water Vapor Ablation System (P160047/S036) | CooperSurgical, Inc. | 2024-05-10 |
| Mater Water Vapor System - Model # GEA-SYS-16-0500, Mara Water Vapor Probe Kit - Model # DDK-16-050, Mara Console - Mode (P160047/S034) | CooperSurgical, Inc. | 2023-12-08 |
| MARA Water Vapor Ablation System (P160047/S033) | CooperSurgical, Inc. | 2023-10-25 |
| Mara Water Vapor Ablation System (P160047/S031) | CooperSurgical, Inc. | 2023-07-28 |
| Mara Water Vapor Ablation System (P160047/S032) | CooperSurgical, Inc. | 2023-07-27 |