Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M
FDA 510(k) K250573 · Olympus Medical Systems Corp.
510(k) numberK250573
Submission
- Device name
- Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M
- Applicant
- Olympus Medical Systems Corp.
Hachioji-Shi, JP - Received
- February 26, 2025
- Decision date
- May 27, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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.
Other 510(k)s with product code ODD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K070420 | Bioshield-Ercp Biopsy Valve, Model 00711138ODD · Traditional | United States Endoscopy Group, Inc. | 03/19/2007SE |
| 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 |
More from Olympus America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262079 | 4K Camera Head OLYMPUS CH-S700-08-LBFET · Traditional | 09/10/2026SE |
| K260856 | Disposable Distal Attachment D-201-13404FDS · Traditional | 08/27/2026SE |
| K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500FDS · Traditional | 08/27/2026SE |
| K260401 | Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)PSV · Traditional | 08/27/2026SE |
| K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)ODG · Traditional | 07/31/2026SE |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional | 07/01/2026SE |
| K261260 | HD Camera Head OLYMPUS CH-S200-08-LBFET · Traditional | 06/24/2026SE |
| K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090…PKL · Traditional | 05/21/2026SE |
| K252341 | Evis Exera III Bronchovideoscope (Olympus BF-Q190); Evis Exera III Bronchovideoscope…EOQ · Traditional | 04/23/2026SE |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DEOB · Traditional | 03/20/2026SE |
Questions and answers
When was Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M cleared by the FDA?
Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M (K250573) received a 510(k) decision of Substantially Equivalent on May 27, 2025, 90 days after the submission was received.
What is the product code of K250573?
The FDA product code is ODD – Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula, a Class II (moderate risk) device regulated under 21 CFR 876.1500.