Microdiscectomy Curette Set
FDA 510(k) K875292 · T. Korossurgical Instruments Corp.
510(k) numberK875292
Submission
- Device name
- Microdiscectomy Curette Set
- Applicant
- T. Korossurgical Instruments Corp.
Moorepark, CA, US - Received
- December 30, 1987
- Decision date
- January 29, 1988
- 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 |
| 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 |
|---|---|---|
| K001915 | Graft Marker RingMAB · Traditional | 04/27/2001SE |
| K002755 | Non-Absorbing Sternatomy Monofilament SutureLRN · Traditional | 12/04/2000SE |
| K954016 | Videoscope W/Irrigation SheathHRX · Traditional | 01/25/1996SN |
| K953998 | Discetome Tissue AspiratorHRX · Traditional | 12/04/1995SE |
| K954052 | Arthroscopic Grasper, Cup Forceps and CurettesHRX · Traditional | 11/06/1995SN |
| K954014 | Percutaneous Discectomy Cannula SystemHRX · Traditional | 11/06/1995SN |
| K935529 | Cervical Self-Retaining RetractorGZT · Traditional | 03/22/1994SE |
| K931262 | Reusable/Interchangeable Shaft, Endoscopic ScissorGCJ · Traditional | 08/06/1993SE |
| K926585 | Thorocoscopy Self-Retaining RetractorGAD · Traditional | 08/06/1993SE |
| K926583 | Reusable Endoscopic Scissors, Grasper-MonopolarGCJ · Traditional | 08/06/1993SE |
Questions and answers
When was Microdiscectomy Curette Set cleared by the FDA?
Microdiscectomy Curette Set (K875292) received a 510(k) decision of Substantially Equivalent on January 29, 1988, 30 days after the submission was received.
What is the product code of K875292?
The FDA product code is FZS – Curette, Surgical, General Use, a Class I (low risk) device regulated under 21 CFR 878.4800.