FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A
K Number: K092359
·
Decision Nov 2, 2009
Classifications
1
FEI Numbers
128
Registration Numbers
128
Same Product Code
132
Applicant Total
32
Review Days
90
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A
- K Number
- K092359
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Ireland, Ltd.
- Date Received
- August 4, 2009
- Decision Date
- November 2, 2009
- Product Code
- FCG
- 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 |
|---|---|---|---|
| FCG | Biopsy Needle | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FCG), ordered by most recent decision date.
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ClearTip FNA and FNB Types
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Precision GI
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ClearTip
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)
FDA 510(k)
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 |
| 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 |