Brush, Biopsy, General & Plastic Surgery
The Brush, Biopsy for General and Plastic Surgery (product code GEE) is a manual surgical instrument used to collect tissue samples for biopsy during general and plastic surgery procedures. It is classified as an FDA Class 1 device, representing the lowest risk category, subject to general controls only and no premarket notification requirement. Regulated under 21 CFR 878.4800 and assigned to the General, Plastic Surgery medical specialty (SU), this instrument is a standard manual surgical tool with no special flags for implantation, life support, or GMP exemption.
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Basic Information
- Product Code
- GEE
- 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 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K854003 | STERILE SOFT TISSUE BIOPSY NEEDLE | Oct 18, 1985 | Substantially Equivalent | Co-Medical, Inc. |
| K841008 | BIOPSY PUNCH, VARIOUS | Jun 08, 1984 | Substantially Equivalent | Premier Dental Products Co. |
| K822490 | DEFLECTING CYTOLOGY BRUSH | Sep 14, 1982 | Substantially Equivalent | Van-Tec, Inc. |
| K820259 | STERILE CYTOLOGY BRUSHES | Mar 05, 1982 | Substantially Equivalent | American Endoscopy, Inc. |
| K812694 | WHISK-R | Oct 26, 1981 | Substantially Equivalent | Medi-Spec |
| K801304 | CAMLOC SYRINGE BIOPSY KIT | Jun 17, 1980 | Substantially Equivalent | Johannah Medical Services, Inc. |
| K792316 | TROTEX II SCREW NEEDLE BIOPSY INSTR. SET | Dec 18, 1979 | Substantially Equivalent | Ursus Konsult AB |
FEI Numbers
This FDA classification entry is associated with 42 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 42 registration numbers. Click on an entry to view related FDA registrations.