14Fr Colon Decompression Set, Macon Colon Decompression Set
FDA 510(k) K171619 · Cook Ireland, Ltd.
510(k) numberK171619
Submission
- Device name
- 14Fr Colon Decompression Set, Macon Colon Decompression Set
- Applicant
- Cook Ireland, Ltd.
Limerick, IE - Received
- June 2, 2017
- Decision date
- August 1, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FEG – Tube, Double Lumen For Intestinal Decompression And/Or Intubation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FEG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K132314 | Medline Anti-Reflux ValveFEG · Traditional | Medline Industries, Inc. | 09/18/2013SE |
| K053410 | Gientriport with Universal Single Lumen AdaptorFEG · Traditional | Kendall | 01/06/2006SE |
| K040388 | Next Generation Salem SumpFEG · Traditional | Kendall | 05/17/2004SE |
| K971354 | Knott NG TubeFEG · Traditional | Michael M. Knott, M.D. | 11/19/1997SE |
| K960176 | Davol Nasogastric Sump Tube W/Prevent FilterFEG · Traditional | C.R. Bard, Inc. | 07/24/1996SE |
| K926073 | Ultravac-Ng(Tm) Nasogastric Sump Suction TubeFEG · Traditional | Surgimark, Inc. | 05/15/1995SE |
| K935781 | Argyle Salem Sump Tube Anti-Reflux Valve Insertion TrayFEG · Traditional | Sherwood Medical Co. | 01/27/1995SESK |
| K921104 | Lopez Valve with NG Sump TubeFEG · Traditional | Icu Medical, Inc. | 10/26/1992SE |
| K900035 | Wilson-Cook Colon Decompression SetFEG · Traditional | Wilson-Cook Medical, Inc. | 03/07/1990SE |
| K880850 | Keith Nasogastric Sump Tube W/Anti-Reflux ValveFEG · Traditional | Kmb Medical Products Co. | 05/26/1988SE |
More from Kmb Medical Products Co.
| 510(k) | Device | Decision |
|---|---|---|
| K261274 | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…KTI · Traditional | 07/24/2026SE |
| K241209 | EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)FCG · Traditional | 07/29/2024SE |
| K233079 | Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen®…FGE · Traditional | 06/14/2024SE |
| K230909 | EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)FCG · Traditional | 05/30/2023SE |
| K213946 | Compass BDS Biliary StentFGE · Traditional | 05/09/2022SE |
| K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…FCG · Traditional | 05/20/2021SE |
| K182980 | Zilver 518 Biliary Stent, Zilver 635 Biliary StentFGE · Special | 11/16/2018SESU |
| K180868 | Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary…FGE · Traditional | 07/06/2018SE |
| K172057 | Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing…FGE · Traditional | 03/09/2018SE |
| K172044 | Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary…FGE · Traditional | 02/27/2018SE |
Questions and answers
When was 14Fr Colon Decompression Set, Macon Colon Decompression Set cleared by the FDA?
14Fr Colon Decompression Set, Macon Colon Decompression Set (K171619) received a 510(k) decision of Substantially Equivalent on August 1, 2017, 60 days after the submission was received.
What is the product code of K171619?
The FDA product code is FEG – Tube, Double Lumen For Intestinal Decompression And/Or Intubation, a Class II (moderate risk) device regulated under 21 CFR 876.5980.