Curette, Surgical, General Use
The Curette, Surgical, General Use (product code FZS) is a manually operated surgical instrument with a scooped or looped tip, used to remove, scrape, or debride tissue, lesions, or other material from body cavities and surfaces during general and plastic surgery procedures. It is classified as FDA Class 1, posing the lowest level of risk, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
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Basic Information
- Product Code
- FZS
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K932493 | SURGICAL CURETTE | Jan 07, 1994 | Substantially Equivalent | Whitney Products, Inc. |
| K902000 | KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD | Aug 21, 1990 | Substantially Equivalent | Kevtek Medical Products, Inc. |
| K892521 | CYMED MICROSKIN(R) DISPOSABLE IRRIGATION SLEEVE | May 01, 1989 | Substantially Equivalent | Cymed, Inc. |
| K891888 | CURRETTES - PIFFARD, WOLF, VIDAL-SCRAPER | Apr 12, 1989 | Substantially Equivalent | Zinnanti Surgical Instruments, Inc. |
| K891334 | ACU-CURETTE | Apr 11, 1989 | Substantially Equivalent | Acuderm, Inc. |
| K890366 | ADENOID CURETTE | Feb 03, 1989 | Substantially Equivalent | Kinetic Medical Products |
| K875292 | MICRODISCECTOMY CURETTE SET | Jan 29, 1988 | Substantially Equivalent | T. Korossurgical Instruments Corp. |
| K871925 | STRAIGHT CUP CURRETTE, 1.7MM | Jun 01, 1987 | Substantially Equivalent | Arthropedics, Inc. |
| K854899 | NOVAK CURETTE | Dec 24, 1985 | Substantially Equivalent | Euro-Med Intl. |
| K854888 | RANDALL CURETTE | Dec 24, 1985 | Substantially Equivalent | Euro-Med Intl. |
| K842701 | HOPPENSTEIN MICROSURGICAL SPINAL INSTRU | Aug 02, 1984 | Substantially Equivalent | Downs Surgical , Ltd. |
| K831367 | PMN VOLZ CURETTES | May 25, 1983 | Substantially Equivalent | 3M Company |
| K831119 | LUO CURRETTES #3211 | May 09, 1983 | Substantially Equivalent | Pmt, Inc. |
| K803178 | ANSPACH MENISECTOMY KNIFE | Feb 13, 1981 | Substantially Equivalent | The Anspach Effort, Inc. |
FEI Numbers
This FDA classification entry is associated with 216 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 216 registration numbers. Click on an entry to view related FDA registrations.