Curelle

by Bioteque Corp. United States 510(k)

510(k) K915491 Product code HHK

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK915491	Date4 Nov 1992Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 11 Oct 2026)

Specification

510(k) · synced 11 Oct 2026

510(k) Number: K915491
FDA Product Code: HHK

Device Class: Class II
Regulation: 21 CFR Part 884.1175
Advisory Committee: Obstetrics/Gynecology
FDA Decision: SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K915491 24 fields · synced 11 Oct 2026