Kevtek(Tm) Laser Drape/Organ Protector/Eye Shield
FDA 510(k) K902000 · Kevtek Medical Products, Inc.
510(k) numberK902000
Submission
- Device name
- Kevtek(Tm) Laser Drape/Organ Protector/Eye Shield
- Applicant
- Kevtek Medical Products, Inc.
Houston, TX, US - Received
- May 2, 1990
- Decision date
- August 21, 1990
- 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 |
| 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 |
More from Downs Surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K902193 | Kevtek Laser-Stop Endotracheal Tube Laser-StopBTR · Traditional | 03/15/1991SE |
Questions and answers
When was Kevtek(Tm) Laser Drape/Organ Protector/Eye Shield cleared by the FDA?
Kevtek(Tm) Laser Drape/Organ Protector/Eye Shield (K902000) received a 510(k) decision of Substantially Equivalent on August 21, 1990, 111 days after the submission was received.
What is the product code of K902000?
The FDA product code is FZS – Curette, Surgical, General Use, a Class I (low risk) device regulated under 21 CFR 878.4800.