510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894415Substantially Equivalent

Dymax Endovaginal Biopsy Guide

Dymax Corp, Pittsburgh PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894415 is the FDA 510(k) clearance record for DYMAX ENDOVAGINAL BIOPSY GUIDE, a class II device, cleared for Dymax Corp on under FDA product code HGL (Transducer, Ultrasonic, Obstetric). FDA records list 7 510(k) clearances for Dymax Corp, from to . As of , FDA records show no recalls naming K894415.

Clearance record

Decision date
Received
(100 days to decision)
Product code
HGL Transducer, Ultrasonic, Obstetric
Regulation
21 CFR 884.2960
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Dymax Corp 604 Epsilon Dr., Pittsburgh PA
Third party review
No

Clearances, product code HGL

Trailing 12 months

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

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