510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K143308Substantially Equivalent

GelPOINT Transvaginal Access Platform

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

K143308 is the FDA 510(k) clearance record for GelPOINT Transvaginal Access Platform, a class II device, cleared for Applied Medical Resources on under FDA product code HEW (Culdoscope (And Accessories)). FDA records list 115 510(k) clearances for Applied Medical Resources, from to . As of , FDA records show no recalls naming K143308.

Clearance record

Decision date
Received
(329 days to decision)
Product code
HEW Culdoscope (And Accessories)
Regulation
21 CFR 884.1640
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Applied Medical Resources 22872 Avenida Empresa, Rancho Santa CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HEW

Trailing 12 months

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

FDA records show no clearances under product code HEW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HEW, 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