Disposable Bending Cannula PR-233Q
FDA 510(k) K011149 · The Olympus Optical Co.
510(k) numberK011149
Submission
- Device name
- Disposable Bending Cannula PR-233Q
- Applicant
- The Olympus Optical Co.
Melville, NY, US - Received
- April 16, 2001
- Decision date
- May 15, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|---|
| 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 |
| K070420 | Bioshield-Ercp Biopsy Valve, Model 00711138ODD · Traditional | United States Endoscopy Group, Inc. | 03/19/2007SE |
| 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 |
|---|---|---|
| K033225 | Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and Ancillary…EOQ · Traditional | 10/16/2003SE |
| K032066 | Sonosurg SystemLFL · Traditional | 10/03/2003SE |
| K031305 | Olympus Ultrasonic Surgical SystemLFL · Traditional | 09/23/2003SE |
| K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type VEOB · Traditional | 07/24/2003SE |
| K032092 | Olympus XCYF-TP3 Cystofiberscope/NephrofiberscopeFCL · Traditional | 07/16/2003SE |
| K031347 | Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8ODG · Traditional | 05/09/2003SE |
| K030194 | XUES-41 Endoscopic Electrosurgical UnitKNS · Traditional | 03/24/2003SE |
| K024138 | Heat Scissors Generator Set and Heat Scissors HandpieceGEI · Traditional | 03/12/2003SE |
| K021962 | Olympus Ultrasonic Surgical SystemLFL · Traditional | 02/12/2003SE |
| K021852 | Olympus PSD-20 Electrosurgical System & Its Associated AccessoriesGEI · Traditional | 02/11/2003SE |
Questions and answers
When was Disposable Bending Cannula PR-233Q cleared by the FDA?
Disposable Bending Cannula PR-233Q (K011149) received a 510(k) decision of Substantially Equivalent on May 15, 2001, 29 days after the submission was received.
What is the product code of K011149?
The FDA product code is ODD – Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula, a Class II (moderate risk) device regulated under 21 CFR 876.1500.