Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S
K172044 is the FDA 510(k) clearance record for Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S, a class II device, cleared for Cook Ireland, Ltd. on under FDA product code FGE (Stents, Drains And Dilators For The Biliary Ducts). FDA records list 34 510(k) clearances for Cook Ireland, Ltd., from to . As of , FDA records show no recalls naming K172044.
Clearance record
- Decision date
- Received
- (236 days to decision)
- Product code
- FGE Stents, Drains And Dilators For The Biliary Ducts
- Regulation
- 21 CFR 876.5010
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Applicant
- Cook Ireland, Ltd. O' Halloran Rd., National Technology Park, Limerick, IE
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code FGE
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 2 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 2 |
| April 2026 | 2 |
| May 2026 | 0 |
| June 2026 | 1 |
| July 2026 | 1 |
| August 2026 | 0 |
| September 2026 | 2 |
| October 2026 | 0 |
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