Product code GEE
- Device name
- Brush, Biopsy, General & Plastic Surgery
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K854003 | STERILE SOFT TISSUE BIOPSY NEEDLE | Co-Medical, Inc. | 1985-10-18 |
| K841008 | BIOPSY PUNCH, VARIOUS | Premier Dental Products Co. | 1984-06-08 |
| K822490 | DEFLECTING CYTOLOGY BRUSH | Van-Tec, Inc. | 1982-09-14 |
| K820259 | STERILE CYTOLOGY BRUSHES | American Endoscopy, Inc. | 1982-03-05 |
| K812694 | WHISK-R | Medi-Spec | 1981-10-26 |
| K801304 | CAMLOC SYRINGE BIOPSY KIT | Johannah Medical Services, Inc. | 1980-06-17 |
| K792316 | TROTEX II SCREW NEEDLE BIOPSY INSTR. SET | Ursus Konsult AB | 1979-12-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850068304851 | SBH | SBH Surgical | 2026-05-08 |
| 00190776420970 | Millennium | Avalign Technologies, Inc. | 2026-04-30 |
| 00860011506355 | SWAB-PAK | Medical Packaging Corporation | 2026-02-18 |
| 00860011506348 | SWAB-PAK | Medical Packaging Corporation | 2026-02-18 |
| 00816207021720 | Biopsy Brush | ENDO-THERAPEUTICS, INC. | 2025-02-26 |
| 06971317521776 | StatLab | Yancheng Huida Medical Instruments Co., Ltd. | 2024-05-01 |
| 06971317521769 | StatLab | Yancheng Huida Medical Instruments Co., Ltd. | 2024-05-01 |
| 00816207021706 | Single Use Brush Biopsy Instrument | ENDO-THERAPEUTICS, INC. | 2022-12-09 |
| 00816207021690 | Single Use Brush Biopsy Instrument | ENDO-THERAPEUTICS, INC. | 2022-12-09 |
| 00816207021041 | Single Use Brush Biopsy Instrument | ENDO-THERAPEUTICS, INC. | 2022-12-09 |
| 00816207021027 | Single Use Brush Biopsy Instrument | ENDO-THERAPEUTICS, INC. | 2022-12-09 |
| 00816207021713 | Single Use Brush Biopsy Instrument | ENDO-THERAPEUTICS, INC. | 2022-12-09 |
| 30653405051057 | CONMED | Conmed Corporation | 2021-10-05 |
| 30653405051040 | CONMED | Conmed Corporation | 2021-10-05 |
| 00860275000361 | Soft K-Cot(R) | HISTOLOGICS, LLC | 2021-07-25 |
| 20763000374871 | Midas Rex | MEDTRONIC POWERED SURGICAL SOLUTIONS | 2020-10-02 |
| 20763000374857 | Midas Rex | MEDTRONIC POWERED SURGICAL SOLUTIONS | 2020-10-02 |
| 20763000374833 | Midas Rex | MEDTRONIC POWERED SURGICAL SOLUTIONS | 2020-10-02 |
| 10653405051060 | CONMED | Conmed Corporation | 2020-09-24 |
| 00860275000316 | SoftBiopsy | HISTOLOGICS, LLC | 2019-11-10 |
| 10653405060444 | CONMED | Conmed Corporation | 2016-09-24 |
| 10653405054078 | NA | Conmed Corporation | 2016-09-24 |
| 10653405054061 | NA | Conmed Corporation | 2016-09-24 |
| 10653405051091 | Harrell | Conmed Corporation | 2016-09-24 |
| 10653405051084 | Harrell | Conmed Corporation | 2016-09-24 |
| 10653405051077 | CONMED | Conmed Corporation | 2016-09-24 |
| 10653405051039 | CONMED | Conmed Corporation | 2016-09-24 |
| 20653405051081 | Harrell | Conmed Corporation | 2016-09-24 |
| 20653405051036 | CONMED | Conmed Corporation | 2016-09-24 |
| M84942910 | Hobbs Nasal Cytology Brush | HOBBS MEDICAL, INC. | 2016-09-21 |