FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
K Number: K013640
·
Decision Feb 4, 2002
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
74
Applicant Total
67
Review Days
91
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Basic Information
- Device Name
- EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
- K Number
- K013640
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pentax Precision Instrument Corp.
- Date Received
- November 5, 2001
- Decision Date
- February 4, 2002
- Product Code
- FDS
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| FDS | Gastroscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Pentax Precision Instrument Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K041396 | FG-36UX FIBER ULTRASOUND GASTROSCOPE | Jun 9, 2004 | Substantially Equivalent |
| K041395 | EG-3630UR | Jun 9, 2004 | Substantially Equivalent |
| K041397 | EG-3830UT | Jun 9, 2004 | Substantially Equivalent |
| K031789 | EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE | Aug 8, 2003 | Substantially Equivalent |
| K023401 | EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE | Feb 11, 2003 | Substantially Equivalent |
| K023376 | EB-1830T3, VIDEO BRONCHOSCOPE | Oct 16, 2002 | Substantially Equivalent |
| K021276 | FG-36UX FIBER ULTRASOUND GASTROSCOPE | Sep 12, 2002 | Substantially Equivalent |
| K021278 | EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE | Sep 6, 2002 | Substantially Equivalent |
| K010740 | FG-36UX, FIBER ULTRASOUND GASTROSCOPE | Apr 17, 2001 | Substantially Equivalent |
| K964815 | AP-4000, AIR PULSE SENSORY STIMULATOR | Sep 4, 1997 | Substantially Equivalent |