LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)— 510(k) K260420
Substantially EquivalentMacroLux Medical Technology Co., Ltd.
FDA 510(k) clearance K260420 for LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG), Substantially Equivalent on 2026-04-08. Applicant: MacroLux Medical Technology Co., Ltd.. Device class: 2.
Summary
MacroLux Medical Technology's LoopView Single-Use Digital Flexible Bronchoscope comes in two models, B27-C and B27-CG, filed under product code EOQ (Bronchoscope (Flexible Or Rigid)). The record doesn't say how the two differ.
Class II, 21 CFR 874.4680. It came in as a Traditional 510(k), and Ear, Nose, and Throat is both the classification panel and the review panel.
MacroLux Medical Technology filed from Shenzhen, China. Review took 58 calendar days (February 9 to April 8, 2026).
Clearance details
- Applicant
- MacroLux Medical Technology Co., Ltd.
- Product code
- Product code EOQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code EOQ
view allMore clearances from MacroLux Medical Technology Co., Ltd.
view all- K260516 — BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
- K250452 — CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B)
- K240978 — SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
- K240283 — BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR) +1 more
- K233779 — LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)
Adverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.