HEW

Culdoscope (And Accessories)

Product code: HEW
Device name: Culdoscope (And Accessories)
Device class: Class 2
21 CFR: 21 CFR 884.1640
Medical specialty: Obstetrics/Gynecology
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 1
Summaries archived here: 1 (direct download)
510(k) clearances (all years, FDA): 18 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-10-02.

Number	Decision date	Applicant	Device name	Summary
K243152	2025-10-02	Applied Medical Resources Corp.	GelPOINT V-Path Transvaginal Access Platform with Re	PDF

1 summaries are archived here for direct download.

Official FDA classification page: HEW

Classification and pathway per current FDA publications. Data from openFDA (CC0).