Acu-Curette
FDA 510(k) K891334 · Acuderm, Inc.
510(k) numberK891334
Submission
- Device name
- Acu-Curette
- Applicant
- Acuderm, Inc.
Ft. Lauderdale, FL, US - Received
- March 10, 1989
- Decision date
- April 11, 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 |
| 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 |
More from Downs Surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K933516 | Acu-E PunchLRY · Traditional | 03/24/1994SE |
| K933265 | Acu-Dispo-Ce(Tm)MDM · Traditional | 03/07/1994SE |
| K933137 | Acu-Suture KitLRO · Traditional | 02/22/1994SE |
| K930043 | Acu-EvacFYD · Traditional | 02/09/1994SE |
| K933866 | Acu-Hemostatic RingMDM · Traditional | 12/01/1993SE |
| K915000 | Acu-GuardGEX · Traditional | 01/27/1992SE |
| K874024 | Acu-Micro-NeedleFMI · Traditional | 11/23/1987SE |
| K854877 | Acu-Syringe W/Wo NeedlesFMF · Traditional | 02/19/1986SE |
| K832583 | Sabouraud Dextrose AgarJSJ · Traditional | 09/12/1983SE |
| K832582 | Mycosel AgarJSJ · Traditional | 09/12/1983SE |
Questions and answers
When was Acu-Curette cleared by the FDA?
Acu-Curette (K891334) received a 510(k) decision of Substantially Equivalent on April 11, 1989, 32 days after the submission was received.
What is the product code of K891334?
The FDA product code is FZS – Curette, Surgical, General Use, a Class I (low risk) device regulated under 21 CFR 878.4800.