LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
FDA 510(k) K260420 · MacroLux Medical Technology Co., Ltd.
Submission
- Device name
- LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
- Applicant
- MacroLux Medical Technology Co., Ltd.
Shenzhen, CN - Received
- February 9, 2026
- Decision date
- April 8, 2026
- 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…
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| K252045 | Ion Endoluminal System (IF1000)EOQ · Traditional | Intuitive Surgical, Inc. | 09/23/2025SE |
| K251894 | Himaging Bronchscope SystemEOQ · Traditional | Himaging Technology (Shanghai) Co., Ltd. | 09/23/2025SE |
More from Himaging Technology (Shanghai) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260516 | BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR…FGB · Traditional | 07/20/2026SE |
| K250452 | CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B…FED · Traditional | 06/02/2025SE |
| K240978 | SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G…HIH · Traditional | 08/16/2024SE |
| K240283 | BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR)…FAJ · Traditional | 06/10/2024SE |
| K233779 | LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C)…EOQ · Traditional | 04/05/2024SE |
| K231774 | CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital…FGB · Traditional | 01/11/2024SE |
Questions and answers
When was LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) cleared by the FDA?
LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) (K260420) received a 510(k) decision of Substantially Equivalent on April 8, 2026, 58 days after the submission was received.
What is the product code of K260420?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.