Biologics · Letter issue date: Oct 6, 2026

Tides Medical LLC

3 extracted findings

FDA source excerpt, selected passage

APLICOR 3D is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) for these devices in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).

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APLICOR 3D is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not timely notify the agency of its intent to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of these devices, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

Because there is evidence that APLICOR 3D is intended for uses that are different from those of legally marketed devices classified under 21 CFR 880.6430, it exceeds the limitations described in 21 CFR 880.9 and is not exempt from premarket notification.

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21 CFR 880.6430 21 CFR 880.9 21 CFR 880.6430(a)

Tides Medical LLC

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