FDA 510(k)
FDA class 2
Unknown
🇮🇪 Ireland
EchoTip Insight Portosystemic Pressure Gradient Measuring System
K Number: DEN180062
·
Decision Nov 20, 2019
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
0
Applicant Total
32
Review Days
366
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Basic Information
- Device Name
- EchoTip Insight Portosystemic Pressure Gradient Measuring System
- K Number
- DEN180062
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 876.1050
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Applicant
- Cook Ireland, Ltd.
- Date Received
- November 19, 2018
- Decision Date
- November 20, 2019
- Product Code
- QIJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| QIJ | Endoscopic Transhepatic Venous Access Needle | FDA class 2 | Gastroenterology, Urology |
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 |
| 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 |
| K171623 | Nasal Pancreatic Drainage Set | Jul 31, 2017 | Substantially Equivalent |