K-number	K250452
Device name	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)
Applicant	MacroLux Medical Technology Co., Ltd.
Product code	FED
Device class	Class II
Decision date	Jun 2, 2025
Decision	Substantially Equivalent
Regulation	876.1500

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The CoralWell Single-use Ureteral Access Sheath is a medical device used during endoscopic urological procedures to establish a conduit that facilitates passage of endoscopes and instruments into the urinary tract for treatment of urinary stones and other urinary diseases.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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