Curette

FDA product code HTF · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery

3510(k) clearances
0PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K890252Bone CuretteHTF · Traditional Kinetic Medical Products01/27/1989SE
K870778Acromed Wallie-Heinig CurettesHTF · Traditional Buckman Co., Inc.03/09/1987SE
K8419794MM Cup CurretteHTF · Traditional Stainless Mfg., Inc.06/19/1984SE

Recalls

RecallProductFirmInitiated
Z-0758-2025 Class IIST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600KWeak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to… MEDLINE INDUSTRIES, LP - Northfield11/12/2024Open, Classified
Z-1439-2024 Class IICenturion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… MEDLINE INDUSTRIES, LP - Northfield02/23/2024Open, Classified