FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PENTAX VIDEO COLONOSCOPES (EC FAMILY)
K Number: K131855
·
Decision Apr 9, 2014
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
111
Applicant Total
12
Review Days
292
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Basic Information
- Device Name
- PENTAX VIDEO COLONOSCOPES (EC FAMILY)
- K Number
- K131855
- 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 Medical Company
- Date Received
- June 21, 2013
- Decision Date
- April 9, 2014
- Product Code
- FDF
- 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 |
|---|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Pentax Medical Company
| K Number | Device Name | ||
|---|---|---|---|
| K131946 | ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS | Apr 25, 2014 | Substantially Equivalent |
| K131028 | PENTAX VIDEO BRONCHOSCOPES (EB FAMILY) | Apr 10, 2014 | Substantially Equivalent |
| K131902 | PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY) | Apr 10, 2014 | Substantially Equivalent |
| K093037 | PENTEX EC-3890LI | Dec 28, 2009 | Substantially Equivalent |
| K092710 | PENTAX ED-3490TK, VIDEO DUODENOSCOPE | Dec 2, 2009 | Substantially Equivalent |
| K090197 | EG-3870UTK | May 19, 2009 | Substantially Equivalent |
| K090196 | EG-3670URK | May 19, 2009 | Substantially Equivalent |
| K081518 | ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK | Sep 5, 2008 | Substantially Equivalent |
| K061068 | EG-3670URK | May 3, 2006 | Substantially Equivalent |
| K042741 | EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE | Oct 19, 2004 | Substantially Equivalent |