Pulmonary Cytology Brush
FDA 510(k) K182927 · Hobbs Medical, Inc.
510(k) numberK182927
Submission
- Device name
- Pulmonary Cytology Brush
- Applicant
- Hobbs Medical, Inc.
Stafford Springs, CT, US - Received
- October 22, 2018
- Decision date
- February 7, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K190293 | Single Use Cytology Brush BC-205DBTG · Traditional | Olympus Medical Systems Corp. | 08/02/2019SE |
| K130357 | Superdimension Triple-Needle Cytology BrushBTG · Traditional | Covidien, LLC | 11/06/2013SE |
| K820771 | Microbiology Specimen BrushBTG · Traditional | Mill-Rose Laboratory | 05/03/1982SE |
| K780872 | Cytology BrushBTG · Traditional | CooperVision, Inc. | 09/07/1978SE |
More from CooperVision, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K241874 | Aspiration Catheter (2189)OCX · Traditional | 09/24/2024SE |
| K093079 | Touchsoft Coagulator with Banana Fitting, Model 4581 and with Universal Fitting, Model…KNS · Traditional | 08/02/2010SE |
| K030765 | Hobbs Mistifier Spray CatheterOCX · Traditional | 06/09/2003SE |
| K933354 | Hobbs Medical Cleaning BrushFEB · Traditional | 10/28/1993SE |
| K922396 | Fujinon Forceps -- ModificationFCL · Traditional | 12/10/1992SE |
| K921026 | Pressure GaugeKNT · Traditional | 04/24/1992SE |
| K914358 | Encapsulated Guidewire with Flexible TipEYB · Traditional | 11/19/1991SE |
| K893729 | Hobbs Medical Microbiology BrushFDX · Traditional | 08/28/1989SE |
| K872509 | Linden Stone Extraction BalloonFGE · Traditional | 09/22/1987SE |
| K860593 | Et/Rt PapillotomeKNS · Traditional | 07/22/1986SE |
Questions and answers
When was Pulmonary Cytology Brush cleared by the FDA?
Pulmonary Cytology Brush (K182927) received a 510(k) decision of Substantially Equivalent on February 7, 2020, 473 days after the submission was received.
What is the product code of K182927?
The FDA product code is BTG – Brush, Biopsy, Bronchoscope (Non-Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.