FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FE-34TH, FIBER ESOPHAGOSCOPE
K Number: K951198
·
Decision May 30, 1995
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
3
Applicant Total
67
Review Days
75
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Basic Information
- Device Name
- FE-34TH, FIBER ESOPHAGOSCOPE
- K Number
- K951198
- 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
- March 16, 1995
- Decision Date
- May 30, 1995
- Product Code
- GCL
- 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 |
|---|---|---|---|
| GCL | Esophagoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCL), ordered by most recent decision date.
FE-24X, FIBER ESOPHAGOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
5,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREAD
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BARD BIOPSY FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |
| K013640 | EG-3630UR, ULTRASUND VIDEO GASTROSCOPE | Feb 4, 2002 | Substantially Equivalent |
| K010740 | FG-36UX, FIBER ULTRASOUND GASTROSCOPE | Apr 17, 2001 | Substantially Equivalent |