Microbiology Specimen Brush
FDA 510(k) K820771 · Mill-Rose Laboratory
510(k) numberK820771
Submission
- Device name
- Microbiology Specimen Brush
- Applicant
- Mill-Rose Laboratory
Mchenry, IL, US - Received
- March 23, 1982
- Decision date
- May 3, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K130357 | Superdimension Triple-Needle Cytology BrushBTG · Traditional | Covidien, LLC | 11/06/2013SE |
| K780872 | Cytology BrushBTG · Traditional | CooperVision, Inc. | 09/07/1978SE |
More from CooperVision, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983124 | Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Cytology Procedural KitEOQ · Traditional | 10/30/1998SE |
| K983122 | Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Combination…EOQ · Traditional | 10/30/1998SE |
| K971275 | Mill-Rose Disposable Polypectomy SnareFDI · Traditional | 05/23/1997SE |
| K962736 | Mill-Rose Laryngoscopic Injection NeedleEOQ · Traditional | 07/29/1996SE |
| K960880 | Mill-Rose Blind Microbiology BrushEOQ · Traditional | 04/29/1996SE |
| K954519 | Wang Transendoscopic Aspiration NeedleFBK · Traditional | 12/22/1995SE |
| K951600 | Mill-Rose Rotatable Polypectomy SnareFDI · Traditional | 12/18/1995SE |
| K954745 | Mill-Rose Rigid Scope Cleaning BrushesFEB · Traditional | 11/27/1995SE |
| K951051 | Rite-Bite Biopsy ForcepsEOQ · Traditional | 03/24/1995SE |
| K951048 | Rite-Bite Biopsy ForcepsFCL · Traditional | 03/15/1995SE |
Questions and answers
When was Microbiology Specimen Brush cleared by the FDA?
Microbiology Specimen Brush (K820771) received a 510(k) decision of Substantially Equivalent on May 3, 1982, 41 days after the submission was received.
What is the product code of K820771?
The FDA product code is BTG – Brush, Biopsy, Bronchoscope (Non-Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.