WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System
FDA 510(k) K220399 · OTU Medical, Inc.
Submission
- Device name
- WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System
- Applicant
- OTU Medical, Inc.
San Jose, CA, US - Received
- February 11, 2022
- Decision date
- June 16, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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…
Other 510(k)s with product code EOQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254026 | 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video…EOQ · Traditional | Flexicare Medical Limited. | 09/02/2026SE |
| K260382 | MONARCH Platform (MON-000008)EOQ · Traditional | Auris Health, Inc. | 07/25/2026SE |
| K254037 | LungFlow Airway CatheterEOQ · Traditional | Free Flow Medical, Inc. | 07/10/2026SE |
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TEOQ · Traditional | Fujifilm Corporation | 06/16/2026SE |
| K260565 | SmartClip Delivery Catheter (ADR-1715)EOQ · Traditional | Elucent Medical | 05/14/2026SE |
| K252341 | Evis Exera III Bronchovideoscope (Olympus BF-Q190); Evis Exera III Bronchovideoscope…EOQ · Traditional | Olympus Medical Systems Corp. | 04/23/2026SE |
| K260420 | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)EOQ · Traditional | MacroLux Medical Technology Co., Ltd. | 04/08/2026SE |
| K250863 | FUJIFILM Ultrasonic Endoscope EB-710USEOQ · Traditional | Fujifilm Corporation | 12/12/2025SE |
| K251731 | KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)EOQ · Special | Karl Storz SE & CO. KG | 12/05/2025SE |
| K252045 | Ion Endoluminal System (IF1000)EOQ · Traditional | Intuitive Surgical, Inc. | 09/23/2025SE |
More from Intuitive Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K231702 | WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope…FAJ · Traditional | 09/29/2023SE |
| K212202 | WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope…FAJ · Traditional | 04/13/2022SE |
| K210579 | WiScope OM Endoscope System, WiScope Single-Use Digital Flexible…FGB · Traditional | 07/22/2021SE |
| K181977 | WiScope Digital Endoscope SystemFGB · Traditional | 08/14/2018SE |
Questions and answers
When was WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System cleared by the FDA?
WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System (K220399) received a 510(k) decision of Substantially Equivalent on June 16, 2022, 125 days after the submission was received.
What is the product code of K220399?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.