Adenoid Curette
FDA 510(k) K890366 · Kinetic Medical Products
510(k) numberK890366
Submission
- Device name
- Adenoid Curette
- Applicant
- Kinetic Medical Products
Erie, PA, US - Received
- January 23, 1989
- Decision date
- February 3, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FZS – Curette, Surgical, General Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FZS
| 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 |
| 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 |
More from Downs Surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K890385 | Midwifery/Obstetrical ForcepsHDA · Traditional | 03/01/1989SE |
| K890387 | Malleable Placenta CuretteHEX · Traditional | 02/27/1989SE |
| K890382 | Compression ForcepsHFW · Traditional | 02/27/1989SE |
| K890380 | Cervical Biopsy ForcepsHFB · Traditional | 02/27/1989SE |
| K890376 | Vaginal SpeculumHFD · Traditional | 02/27/1989SE |
| K890383 | Hysterectomy ForcepsHCZ · Traditional | 02/16/1989SE |
| K890216 | Microsurgical KeratomeGZX · Traditional | 02/16/1989SE |
| K890389 | Umbilical ScissorsHDJ · Traditional | 02/13/1989SE |
| K890388 | Cephalotomy ScissorsKNB · Traditional | 02/13/1989SE |
| K890386 | Placenta and Ovum ForcepsHCZ · Traditional | 02/13/1989SE |
Questions and answers
When was Adenoid Curette cleared by the FDA?
Adenoid Curette (K890366) received a 510(k) decision of Substantially Equivalent on February 3, 1989, 11 days after the submission was received.
What is the product code of K890366?
The FDA product code is FZS – Curette, Surgical, General Use, a Class I (low risk) device regulated under 21 CFR 878.4800.