Bioshield-Ercp Biopsy Valve, Model 00711138
FDA 510(k) K070420 · United States Endoscopy Group, Inc.
510(k) numberK070420
Submission
- Device name
- Bioshield-Ercp Biopsy Valve, Model 00711138
- Applicant
- United States Endoscopy Group, Inc.
Mentor, OH, US - Received
- February 20, 2007
- Decision date
- March 19, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- ODD – Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To identify stones, tumors, or narrowing in the biliary tree.
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| K250573 | Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use…ODD · Traditional | Olympus Medical Systems Corp. | 05/27/2025SE |
| K202583 | BioShield biopsy valve EUS - LinearODD · Traditional | STERIS Corporation | 11/06/2020SE |
| K171989 | Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled…ODD · Traditional | Wilson-Cook Medical, Inc. | 03/20/2018SE |
| K011149 | Disposable Bending Cannula PR-233QODD · Special | The Olympus Optical Co. | 05/15/2001SE |
| K010993 | Alien RX Micro Cannula, Model 4530ODD · Special | Boston Scientific Corp | 04/30/2001SE |
| K973205 | Wilson-Cook Stricture Measuring CatheterODD · Traditional | Wilson-Cook Medical, Inc. | 11/24/1997SE |
| K963051 | Ercp CannulaODD · Traditional | United States Endoscopy Group, Inc. | 03/28/1997SE |
| K953967 | Endoscopic CatheterODD · Traditional | Act Medical, Inc. | 01/22/1996SE |
| K950700 | Bard Bilisystem Endoscopic Retrograde Cholangiopancreatography (Ercp) CannulaODD · Traditional | C.R. Bard, Inc. | 04/27/1995SE |
| K950729 | Olympus PR-23Q Disposable Cannula (Ball Tip)ODD · Traditional | Olympus America, Inc. | 03/17/1995SE |
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| K182258 | AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - FujifilmFEQ · Special | 09/21/2018SE |
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| K172805 | gi-4000 Electrosurgical GeneratorGEI · Special | 10/23/2017SE |
| K163495 | AdvanCE capsule endoscope delivery deviceNEZ · Traditional | 03/10/2017SE |
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Questions and answers
When was Bioshield-Ercp Biopsy Valve, Model 00711138 cleared by the FDA?
Bioshield-Ercp Biopsy Valve, Model 00711138 (K070420) received a 510(k) decision of Substantially Equivalent on March 19, 2007, 27 days after the submission was received.
What is the product code of K070420?
The FDA product code is ODD – Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula, a Class II (moderate risk) device regulated under 21 CFR 876.1500.