K-number	K242586
Device name	ArgoCap (200.52)
Applicant	Ovesco Endoscopy AG
Product code	OCX
Device class	Class II
Decision date	May 22, 2025
Decision	Substantially Equivalent
Regulation	876.1500

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The ArgoCap is a cap device attached to the distal end of an endoscope to facilitate endoscopic therapy. It is intended for gastrointestinal endoscopic mucosal resection and coagulation, and for maintaining the suitable depth of the endoscope's view field during procedures.

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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ArgoCap (200.52)

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