Surgical Curette
FDA 510(k) K932493 · Whitney Products, Inc.
510(k) numberK932493
Submission
- Device name
- Surgical Curette
- Applicant
- Whitney Products, Inc.
Glenview, IL, US - Received
- May 24, 1993
- Decision date
- January 7, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| 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 |
Questions and answers
When was Surgical Curette cleared by the FDA?
Surgical Curette (K932493) received a 510(k) decision of Substantially Equivalent on January 7, 1994, 228 days after the submission was received.
What is the product code of K932493?
The FDA product code is FZS – Curette, Surgical, General Use, a Class I (low risk) device regulated under 21 CFR 878.4800.