Randall Curette
FDA 510(k) K854888 · Euro-Med Intl.
510(k) numberK854888
Submission
- Device name
- Randall Curette
- Applicant
- Euro-Med Intl.
Danville, CA, US - Received
- December 6, 1985
- Decision date
- December 24, 1985
- 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 |
| 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 |
| K842701 | Hoppenstein Microsurgical Spinal InstruFZS · Traditional | Downs Surgical , Ltd. | 08/02/1984SE |
More from Downs Surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K883884 | Prostatic Core-Cut NeedleKNW · Traditional | 12/05/1988SE |
| K882404 | Kevor-CurettePCF · Traditional | 07/08/1988SE |
| K854901 | Pacific GrasperKDC · Traditional | 05/02/1986SE |
| K854898 | Atlantic GrasperKDC · Traditional | 05/02/1986SE |
| K854897 | Max-I-GraspKDC · Traditional | 05/02/1986SE |
| K854896 | Hook ScissorKDC · Traditional | 05/02/1986SE |
| K854895 | Basket ForcepKDC · Traditional | 05/02/1986SE |
| K854894 | SpoonKDC · Traditional | 05/02/1986SE |
| K854891 | KnifeEMF · Traditional | 05/02/1986SE |
| K854890 | Hook ProbeKDC · Traditional | 05/02/1986SE |
Questions and answers
When was Randall Curette cleared by the FDA?
Randall Curette (K854888) received a 510(k) decision of Substantially Equivalent on December 24, 1985, 18 days after the submission was received.
What is the product code of K854888?
The FDA product code is FZS – Curette, Surgical, General Use, a Class I (low risk) device regulated under 21 CFR 878.4800.