14Fr Colon Decompression Set, Macon Colon Decompression Set
FDA 510(k) clearance K171619 · decided 2017-08-01
Clearance details
- K-number
- K171619
- Device name
- 14Fr Colon Decompression Set, Macon Colon Decompression Set
- Applicant
- Cook Ireland, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-06-02
- Decision date
- 2017-08-01
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- FEG
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Limerick, IE
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| MEDLINE ANTI-REFLUX VALVE (K132314) | Medline Industries, Inc. | 2013-09-18 |
| GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR (K053410) | Kendall | 2006-01-06 |
| NEXT GENERATION SALEM SUMP (K040388) | Kendall | 2004-05-17 |
| KNOTT NG TUBE (K971354) | Michael M. Knott, M.D. | 1997-11-19 |
| DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER (K960176) | C.R. Bard, Inc. | 1996-07-24 |
| ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBE (K926073) | Surgimark, Inc. | 1995-05-15 |
| ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY (K935781) | Sherwood Medical Co. | 1995-01-27 |
| LOPEZ VALVE WITH NG SUMP TUBE (K921104) | Icu Medical, Inc. | 1992-10-26 |
| WILSON-COOK COLON DECOMPRESSION SET (K900035) | Wilson-Cook Medical, Inc. | 1990-03-07 |
| KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE (K880850) | Kmb Medical Products Co. | 1988-05-26 |
| HODGE TUBE (K772282) | Mallinckrodt Critical Care | 1978-03-09 |
| CATHETERS, DRAINAGE (K771048) | Axiom Medical, Inc. | 1977-07-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Zilver Flex® 35 Vascular Stent (P050017/S025) | Cook Ireland, Ltd. | 2025-10-22 |
| Zilver® PTX® Peripheral Drug-Eluting Stent (P100022/S044) | Cook Ireland, Ltd. | 2025-07-03 |
| Zilver Flex(R) 35 Vascular Stent (P050017/S024) | Cook Ireland, Ltd. | 2025-07-01 |
| Zilver PTX Peripheral Drug-Eluting Stent (P100022/S043) | Cook Ireland, Ltd. | 2024-12-20 |
| Zilver® Vascular Stent (P050017/S023) | Cook Ireland, Ltd. | 2024-05-14 |
| Zilver Vena® Venous Self-Expanding Stent (P200023/S008) | Cook Ireland, Ltd. | 2024-05-14 |
| Zilver Vena Venous Self-Expanding Stent (P200023/S007) | Cook Ireland, Ltd. | 2024-02-08 |
| Zilver® PTX® Peripheral Drug- Eluting Stent (P100022/S042) | Cook Ireland, Ltd. | 2023-09-22 |