510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020628Substantially Equivalent

Curelle, Preferred Curelle, Cuteq 2.5

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

K020628 is the FDA 510(k) clearance record for CURELLE, PREFERRED CURELLE, CUTEQ 2.5, a class II device, cleared for Bioteque America, Inc. on under FDA product code HHK (Curette, Suction, Endometrial (And Accessories)). FDA records list 10 510(k) clearances for Bioteque America, Inc., from to . As of , FDA records show no recalls naming K020628.

Clearance record

Decision date
Received
(87 days to decision)
Product code
HHK Curette, Suction, Endometrial (And Accessories)
Regulation
21 CFR 884.1175
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 HHK

Trailing 12 months

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

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