Ultrasound Bronchoscope
The Ultrasound Bronchoscope is an endoscopic device that combines ultrasonic imaging with bronchoscopic access, indicated for ultrasonic visualization, diagnosis, and therapeutic access to the bronchial tree or lungs in the Radiology specialty. It is classified as FDA Class 2 under 21 CFR 892.1550, requiring 510(k) premarket notification; if reusable, the submission must include validated reprocessing instructions and validation data. Product code PSV; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PSV
- Device Class
- FDA class 2
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
Definition
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K183525 | EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F | Sep 06, 2019 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K070983 | OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM | Jul 05, 2007 | Substantially Equivalent | Olympus Medical Systems Corporation |
| K021204 | OLYMPUS BF TYPE UM40 | May 01, 2002 | Substantially Equivalent | Olympus Optical Co., Ltd. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.