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)— 510(k) K250452

Clearance details

Applicant

MacroLux Medical Technology Co., Ltd.

Product code

Code FED

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2025-02-18

Decision date

2025-06-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shenzhen, CN

• K260410 — Single Use Ureteral Access Sheath2026-09-11
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• K260965 — CVAC Aspiration System2026-04-13
• K260521 — ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)2026-04-06
• K252572 — Prodeon Urethral Sheath System2025-10-07

• K260516 — BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)2026-07-20
• K260420 — LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)2026-04-08
• K240978 — SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)2024-08-16
• K240283 — BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR) +1 more2024-06-10
• K233779 — LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)2024-04-05

Death

10

Total

10

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →