Olympus BF Type UM40
FDA 510(k) K021204 · Olympus Optical Co., Ltd.
510(k) numberK021204
Submission
- Device name
- Olympus BF Type UM40
- Applicant
- Olympus Optical Co., Ltd.
Melville, NY, US - Received
- April 16, 2002
- Decision date
- May 1, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- PSV – Ultrasound Bronchoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1550
- Specialty
- Radiology
An ultrasound bronchoscope is indicated for the ultrasonic visualization, diagnosis and therapeutic access to the bronchial tree or the lungs. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code PSV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260401 | Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)PSV · Traditional | Olympus Medical Systems Corporation | 08/27/2026SE |
| K183525 | EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FPSV · Traditional | Olympus Medical Systems Corp. | 09/06/2019SE |
| K070983 | Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka Ssd-Alpha 5/10…PSV · Traditional | Olympus Medical Systems Corporation | 07/05/2007SE |
More from Olympus Medical Systems Corporation
| 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 Olympus BF Type UM40 cleared by the FDA?
Olympus BF Type UM40 (K021204) received a 510(k) decision of Substantially Equivalent on May 1, 2002, 15 days after the submission was received.
What is the product code of K021204?
The FDA product code is PSV – Ultrasound Bronchoscope, a Class II (moderate risk) device regulated under 21 CFR 892.1550.