FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GASTROINTESTINAL SHEATH BRUSH
K Number: K834402
·
Decision Feb 4, 1984
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
43
Applicant Total
21
Review Days
52
Basic Information
- Device Name
- GASTROINTESTINAL SHEATH BRUSH
- K Number
- K834402
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Hobbs Medical, Inc.
- Date Received
- December 14, 1983
- Decision Date
- February 4, 1984
- Product Code
- FDX
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FDX | Endoscopic Cytology Brush | 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 |
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| 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 |