FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150
K Number: K980350
·
Decision Apr 28, 1998
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
17
Review Days
90
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Basic Information
- Device Name
- VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150
- K Number
- K980350
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cuda Products Co.
- Date Received
- January 28, 1998
- Decision Date
- April 28, 1998
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Cuda Products Co.
| K Number | Device Name | ||
|---|---|---|---|
| K983277 | LIGHTSOURCE OR ILLUMINATOR MODEL I-100 | Dec 16, 1998 | Substantially Equivalent |
| K981962 | CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE | Aug 18, 1998 | Substantially Equivalent |
| K981469 | CERMAX300 LIGHTSOURCE | Jul 9, 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 |