FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOBBS MEDICAL CLEANING BRUSH
K Number: K933354
·
Decision Oct 28, 1993
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
56
Applicant Total
21
Review Days
111
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Basic Information
- Device Name
- HOBBS MEDICAL CLEANING BRUSH
- K Number
- K933354
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hobbs Medical, Inc.
- Date Received
- July 9, 1993
- Decision Date
- October 28, 1993
- Product Code
- FEB
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FEB | Accessories, Cleaning, For Endoscope | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Hobbs Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K241874 | Aspiration Catheter (2189) | Sep 24, 2024 | Substantially Equivalent |
| K182927 | Pulmonary Cytology Brush | Feb 7, 2020 | 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 |
| 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 |