Curette, Surgical, General Use
FDA product code FZS · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
14510(k) clearances
0PMA approvals
3recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K932493 | Surgical CuretteFZS · Traditional | Whitney Products, Inc. | 01/07/1994SE |
| K902000 | Kevtek(Tm) Laser Drape/Organ Protector/Eye ShieldFZS · Traditional | Kevtek Medical Products, Inc. | 08/21/1990SE |
| K892521 | Cymed Microskin(R) Disposable Irrigation SleeveFZS · Traditional | Cymed, Inc. | 05/01/1989SE |
| K891888 | Currettes - Piffard, Wolf, Vidal-ScraperFZS · Traditional | Zinnanti Surgical Instruments, Inc. | 04/12/1989SE |
| K891334 | Acu-CuretteFZS · Traditional | Acuderm, Inc. | 04/11/1989SE |
| K890366 | Adenoid CuretteFZS · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K875292 | Microdiscectomy Curette SetFZS · Traditional | T. Korossurgical Instruments Corp. | 01/29/1988SE |
| K871925 | Straight Cup Currette, 1.7MMFZS · Traditional | Arthropedics, Inc. | 06/01/1987SE |
| K854899 | Novak CuretteFZS · Traditional | Euro-Med Intl. | 12/24/1985SE |
| K854888 | Randall CuretteFZS · Traditional | Euro-Med Intl. | 12/24/1985SE |
| K842701 | Hoppenstein Microsurgical Spinal InstruFZS · Traditional | Downs Surgical , Ltd. | 08/02/1984SE |
| K831367 | PMN Volz CurettesFZS · Traditional | 3M Company | 05/25/1983SE |
| K831119 | Luo Currettes #3211FZS · Traditional | Pmt, Inc. | 05/09/1983SE |
| K803178 | Anspach Menisectomy KnifeFZS · Traditional | The Anspach Effort, Inc. | 02/13/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0931-2025 Class II | ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL…Reports of various packaging issues that may result in a breach of the sterile barrier. | Sklar Instruments | 12/03/2024Open, Classified |
| Z-0587-2014 Class II | DIST LAT FEM LOCK PLT, LTBased on a review of historic packaging validations, it was determined that a subset of product packaged at… | Zimmer, Inc. | 11/05/2013Terminated |
| Z-0034-2012 | Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941…The firm learned that the Torque Driver Handles were not actuating at a proper torque. It was determined… | X Spine Systems Inc | 07/15/2011Terminated |