Superdimension Triple-Needle Cytology Brush
FDA 510(k) K130357 · Covidien, LLC
510(k) numberK130357
Submission
- Device name
- Superdimension Triple-Needle Cytology Brush
- Applicant
- Covidien, LLC
Plymouth, MN, US - Received
- February 13, 2013
- Decision date
- November 6, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTG – Brush, Biopsy, Bronchoscope (Non-Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Specialty
- Ear, Nose, Throat
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code BTG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251279 | Disposable Cytology Brush BC-202D/203D SeriesBTG · Traditional | Olympus Medical Systems Corporation | 06/12/2025SE |
| K182927 | Pulmonary Cytology BrushBTG · Traditional | Hobbs Medical, Inc. | 02/07/2020SE |
| K190293 | Single Use Cytology Brush BC-205DBTG · Traditional | Olympus Medical Systems Corp. | 08/02/2019SE |
| K820771 | Microbiology Specimen BrushBTG · Traditional | Mill-Rose Laboratory | 05/03/1982SE |
| K780872 | Cytology BrushBTG · Traditional | CooperVision, Inc. | 09/07/1978SE |
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Questions and answers
When was Superdimension Triple-Needle Cytology Brush cleared by the FDA?
Superdimension Triple-Needle Cytology Brush (K130357) received a 510(k) decision of Substantially Equivalent on November 6, 2013, 266 days after the submission was received.
What is the product code of K130357?
The FDA product code is BTG – Brush, Biopsy, Bronchoscope (Non-Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.