GlideScope BFlex 3.8 Single-Use Bronchoscope
FDA 510(k) K193488 · Verathon Medical (Canada) Ulc
510(k) numberK193488
Submission
- Device name
- GlideScope BFlex 3.8 Single-Use Bronchoscope
- Applicant
- Verathon Medical (Canada) Ulc
Burnaby, CA - Received
- December 17, 2019
- Decision date
- January 16, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EOQ – Bronchoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Specialty
- Ear, Nose, Throat
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated…
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| K253696 | CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse…FAJ · Traditional | 05/11/2026SE |
| K230948 | BFlex 2 Slim 3.8 Single-Use BronchoscopeEOQ · Special | 05/03/2023SE |
| K211947 | GlideScope BFlex 2.8 Single-Use BronchoscopeEOQ · Traditional | 11/03/2021SE |
| K191948 | GlideScope BFlex 5.8 Single-Use BronchoscopeEOQ · Special | 08/21/2019SE |
| K183256 | GlideScope BFlex Single-Use Bronchoscope SystemEOQ · Traditional | 01/04/2019SE |
Questions and answers
When was GlideScope BFlex 3.8 Single-Use Bronchoscope cleared by the FDA?
GlideScope BFlex 3.8 Single-Use Bronchoscope (K193488) received a 510(k) decision of Substantially Equivalent on January 16, 2020, 30 days after the submission was received.
What is the product code of K193488?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.