GlideScope BFlex Single-Use Bronchoscope System
FDA 510(k) K183256 · Verathon Medical (Canada) Ulc
510(k) numberK183256
Submission
- Device name
- GlideScope BFlex Single-Use Bronchoscope System
- Applicant
- Verathon Medical (Canada) Ulc
Burnaby, CA - Received
- November 21, 2018
- Decision date
- January 4, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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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More from Intuitive Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K193488 | GlideScope BFlex 3.8 Single-Use BronchoscopeEOQ · Special | 01/16/2020SE |
| K191948 | GlideScope BFlex 5.8 Single-Use BronchoscopeEOQ · Special | 08/21/2019SE |
Questions and answers
When was GlideScope BFlex Single-Use Bronchoscope System cleared by the FDA?
GlideScope BFlex Single-Use Bronchoscope System (K183256) received a 510(k) decision of Substantially Equivalent on January 4, 2019, 44 days after the submission was received.
What is the product code of K183256?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.