Gunze Limited FDA Approvals

0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
NEOVEIL Staple Line Reinforcement510(k)Aug 26, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Aug 26, 2022
PELNAC Meshed Bilayer Wound Matrix510(k)Jul 14, 2022	—	510(k)Substantially Equivalent (Traditional)	Jul 14, 2022
PELNAC Wound Matrix510(k)Feb 9, 2022	—	510(k)Substantially Equivalent (Traditional)	Feb 9, 2022