Cleared Traditional

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)

K250452 · MacroLux Medical Technology Co., Ltd. · Gastroenterology & Urology

Jun 2025

Decision

104d

Days

Class 2

Risk

About This 510(k) Submission

K250452 is an FDA 510(k) clearance for the 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), a Endoscopic Access Overtube, Gastroenterology-urology (Class II — Special Controls, product code FED), submitted by MacroLux Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 2, 2025, 104 days after receiving the submission on February 18, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K250452 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 18, 2025
Decision Date	June 02, 2025
Days to Decision	104 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement

Device Classification

Product Code	FED — Endoscopic Access Overtube, Gastroenterology-urology
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation.