FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
EVOLUTION COLONIC STENT SYSTEM
K Number: K113510
·
Decision May 17, 2012
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
15
Applicant Total
32
Review Days
171
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Basic Information
- Device Name
- EVOLUTION COLONIC STENT SYSTEM
- K Number
- K113510
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3610
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Ireland, Ltd.
- Date Received
- November 28, 2011
- Decision Date
- May 17, 2012
- Product Code
- MQR
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQR | Stent, Colonic, Metallic, Expandable | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQR), ordered by most recent decision date.
WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
FDA 510(k)
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WallFlex Colonic Stent System with Anchor Lock Delivery System
FDA 510(k)
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WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HANAROSTENT LowAx Colon/Rectum (NNN)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Cook Ireland, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K241209 | EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19) | Jul 29, 2024 | Substantially Equivalent |
| K233079 | Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF) | Jun 14, 2024 | Substantially Equivalent |
| K230909 | EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22) | May 30, 2023 | Substantially Equivalent |
| K213946 | Compass BDS Biliary Stent | May 9, 2022 | Substantially Equivalent |
| K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle | May 20, 2021 | Substantially Equivalent |
| DEN180062 | EchoTip Insight Portosystemic Pressure Gradient Measuring System | Nov 20, 2019 | Unknown |
| K182980 | Zilver 518 Biliary Stent, Zilver 635 Biliary Stent | Nov 16, 2018 | Unknown |
| K172057 | Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set | Mar 9, 2018 | Substantially Equivalent |
| K172044 | 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 | Feb 27, 2018 | Substantially Equivalent |
| K171619 | 14Fr Colon Decompression Set, Macon Colon Decompression Set | Aug 1, 2017 | Substantially Equivalent |