Prosthesis, Breast, External, Used With Adhesive

FDA product code KCZ · Class I (low risk) · 21 CFR 878.3800 · General, Plastic Surgery

13510(k) clearances
0PMA approvals
1recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K990458Straumann Extraoral Implant SystemKCZ · Traditional Straumann USA04/16/1999SE
K951324Maxol Image II Patient Matched Breast ProsthesisKCZ · Traditional Maxol Limited L.C.05/26/1995SE
K933465CosmetKCZ · Traditional Great Bay Medical Products, Inc.07/20/1994SE
K932978Calssique or MystiqueKCZ · Traditional Dekumed, Kunststofftechnik Degler GmbH12/22/1993SE
K932899ClassiqueKCZ · Traditional Hemispheres Marketing Co. , Ltd.12/16/1993SE
K933668Almost U, Inc. Breast ProsthesisKCZ · Traditional Almost U., Inc.12/10/1993SE
K921535Suoena Affinity (TM) Model #802KCZ · Traditional Coloplast Corp.05/11/1992SE
K915382Amoena Affinity Model #802KCZ · Traditional Coloplast Corp.01/14/1992SE
K911247Yours Truly Asymmetrical Breast FormKCZ · Traditional Jobst Institute, Inc.03/29/1991SE
K904085Ella Breast FormKCZ · Traditional Coloplast A/S10/31/1990SE
K904316Nouvelle (TM) Model #901, Sizes 0-12, Left & RightKCZ · Traditional Coloplast Corp.10/11/1990SE
K904086Discrene Self-Supporting Breast FormKCZ · Traditional Coloplast A/S10/02/1990SE
K896533Spenco Breast FormsKCZ · Traditional Spenco Medical Corp.12/13/1989SE

Recalls

RecallProductFirmInitiated
Z-1077-2020 Class IICenturion-Trays EBSI1021 VALVE CHANGE KIT- DOUBLEIncomplete seals on the sterile package may compromise the sterility Centurion Medical Products Corporation12/11/2019Terminated