510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003380Substantially Equivalent

Bioteque Vaginal Dilator

Bioteque America Inc, Langhorne PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003380 is the FDA 510(k) clearance record for BIOTEQUE VAGINAL DILATOR, a class II device, cleared for Bioteque America, Inc. on under FDA product code HDX (Dilator, Vaginal). FDA records list 10 510(k) clearances for Bioteque America, Inc., from to . As of , FDA records show no recalls naming K003380.

Clearance record

Decision date
Received
(90 days to decision)
Product code
HDX Dilator, Vaginal
Regulation
21 CFR 884.3900
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Bioteque America, Inc. 340 E. Maple Ave., #204-C, Langhorne PA
510(k) summary
Statement
Third party review
No

Clearances, product code HDX

Trailing 12 months

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

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