510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220969Substantially Equivalent

GelPOINT V-Path Vaginal Access System

Applied Medical Resources Corp, Rancho Santa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220969 is the FDA 510(k) clearance record for GelPOINT V-Path Vaginal Access System, a class II device, cleared for Applied Medical Resources Corporation on under FDA product code MOK (Vaginoscope And Accessories). FDA records list 115 510(k) clearances for Applied Medical Resources Corporation, from to . As of , FDA records show no recalls naming K220969.

Clearance record

Decision date
Received
(165 days to decision)
Product code
MOK Vaginoscope And Accessories
Regulation
21 CFR 884.1630
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Applied Medical Resources Corporation 22872 Avenida Empresa, Rancho Santa CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MOK

Trailing 12 months

FDA records hold no clearances under product code MOK in the trailing twelve months.

FDA records show no clearances under product code MOK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MOK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260