FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Pulmonary Cytology Brush
K Number: K182927
·
Decision Feb 7, 2020
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
5
Applicant Total
21
Review Days
473
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Pulmonary Cytology Brush
- K Number
- K182927
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hobbs Medical, Inc.
- Date Received
- October 22, 2018
- Decision Date
- February 7, 2020
- Product Code
- BTG
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTG | Brush, Biopsy, Bronchoscope (Non-Rigid) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTG), ordered by most recent decision date.
Disposable Cytology Brush BC-202D/203D Series
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Single Use Cytology Brush BC-205D
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MICROBIOLOGY SPECIMEN BRUSH
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CYTOLOGY BRUSH
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Hobbs Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K241874 | Aspiration Catheter (2189) | Sep 24, 2024 | Substantially Equivalent |
| K093079 | TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U | Aug 2, 2010 | Substantially Equivalent |
| K030765 | HOBBS MISTIFIER SPRAY CATHETER | Jun 9, 2003 | Substantially Equivalent |
| K933354 | HOBBS MEDICAL CLEANING BRUSH | Oct 28, 1993 | Substantially Equivalent |
| K922396 | FUJINON FORCEPS -- MODIFICATION | Dec 10, 1992 | Substantially Equivalent |
| K921026 | PRESSURE GAUGE | Apr 24, 1992 | Substantially Equivalent |
| K914358 | ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP | Nov 19, 1991 | Substantially Equivalent |
| K893729 | HOBBS MEDICAL MICROBIOLOGY BRUSH | Aug 28, 1989 | Substantially Equivalent |
| K872509 | LINDEN STONE EXTRACTION BALLOON | Sep 22, 1987 | Substantially Equivalent |
| K860593 | ET/RT PAPILLOTOME | Jul 22, 1986 | Substantially Equivalent |