510(k) K130357
- Device
- SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH
- Applicant
- Covidien LLC
- 510(k) number
- K130357
- Product code
- BTG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-11-06
- Date received
- 2013-02-13
- Regulation
- 874.4680
- Classification name
- Brush, Biopsy, Bronchoscope (non-rigid)
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KRISTEN SWANSON
- Address
- 161 Cheshire Ln., Suite 100 Plymouth MN US 55441 55441
FDA Registration Numbers#
- 9681260
- 1220592
- 1828132
- 1320894
- 3014769442
- 3018094310
- 1000121056
- 9614641
- 2246552
- 3004962788
- 1223925
- 3005099803
- 1820334
- 3043226252
- 3007305485
- 8010047
- 3012494290
- 1721686
Source Documents#
Other 510(k) Records For Product Code BTG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251279 | Disposable Cytology Brush BC-202D/203D Series | Olympus Medical Systems Corporation | 2025-06-12 |
| K182927 | Pulmonary Cytology Brush | Hobbs Medical, Inc. | 2020-02-07 |
| K190293 | Single Use Cytology Brush BC-205D | Olympus Medical Systems Corp. | 2019-08-02 |
| K820771 | MICROBIOLOGY SPECIMEN BRUSH | Mill-Rose Laboratory | 1982-05-03 |
| K780872 | CYTOLOGY BRUSH | CooperVision, Inc. | 1978-09-07 |
Legacy Summary#
summary
FDA Review#
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