FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIGHTSOURCE OR ILLUMINATOR MODEL I-100
K Number: K983277
·
Decision Dec 16, 1998
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
27
Applicant Total
17
Review Days
90
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
- LIGHTSOURCE OR ILLUMINATOR MODEL I-100
- K Number
- K983277
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cuda Products Co.
- Date Received
- September 17, 1998
- Decision Date
- December 16, 1998
- Product Code
- HBI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| HBI | Illuminator, Fiberoptic, Surgical Field | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HBI), ordered by most recent decision date.
Light-Guide Cables
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OptiLux LED Illuminator
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KOGENT SPETZLER LIGHTED SUCTION TUBES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIGHT GUIDE CABLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
1125 XSB XENON FIBER-OPTIC LIGHT SOURCE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDOSCOPIC FIBEROPTIC CABLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Cuda Products Co.
| K Number | Device Name | ||
|---|---|---|---|
| K981962 | CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE | Aug 18, 1998 | Substantially Equivalent |
| K981469 | CERMAX300 LIGHTSOURCE | Jul 9, 1998 | Substantially Equivalent |
| K980350 | VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150 | Apr 28, 1998 | Substantially Equivalent |
| K980166 | LIGHTSOURCE OR ILLUMINATOR | Apr 1, 1998 | Substantially Equivalent |
| K961074 | LIGHTSOURCE OR ILLUMINATOR | Apr 30, 1996 | Substantially Equivalent |
| K951019 | INTRAORAL VIDEO SCOPE AND WINDOW TUBE | May 10, 1995 | Substantially Equivalent |
| K943731 | VIDEO OTOSCOPE | Oct 11, 1994 | Substantially Equivalent |
| K935818 | ENDOSCOPE | Jul 13, 1994 | Substantially Equivalent |
| K933369 | CUDA PRODUCTS CORP. LIGHTSOURCES | Jan 3, 1994 | Substantially Equivalent |
| K934337 | CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE | Nov 18, 1993 | Substantially Equivalent |