FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U
K Number: K093079
·
Decision Aug 2, 2010
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
187
Applicant Total
21
Review Days
306
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Basic Information
- Device Name
- TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U
- K Number
- K093079
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hobbs Medical, Inc.
- Date Received
- September 30, 2009
- Decision Date
- August 2, 2010
- Product Code
- KNS
- 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 |
|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Hobbs Medical, Inc.
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|---|---|---|---|
| K241874 | Aspiration Catheter (2189) | Sep 24, 2024 | Substantially Equivalent |
| K182927 | Pulmonary Cytology Brush | Feb 7, 2020 | 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 |