Name: Predicase
Price: 199 USD

K-number	K243152
Device name	GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
Applicant	Applied Medical Resources Corp.
Product code	HEW
Device class	Class II
Decision date	Oct 2, 2025
Decision	Substantially Equivalent
Regulation	884.1640

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device

Everything you need for a 510(k) submission. Nothing you don't.