FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR
K Number: K083788
·
Decision Mar 3, 2009
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
27
Applicant Total
5
Review Days
74
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Basic Information
- Device Name
- ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR
- K Number
- K083788
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endooptiks, Inc.
- Date Received
- December 19, 2008
- Decision Date
- March 3, 2009
- Product Code
- EYB
- 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 |
|---|---|---|---|
| EYB | Catheter, Ureteral, Gastro-Urology | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Endooptiks, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042918 | MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2 | Nov 22, 2004 | Substantially Equivalent |
| K003151 | MICROPOBE SERIES OF LASERS AND ACCESSORIES | Jan 8, 2001 | Substantially Equivalent |
| K945081 | TRANSTYMPANIC ENDOSCOPE | Mar 6, 1995 | Substantially Equivalent |
| K922917 | ENDOPROBES | Sep 28, 1992 | Substantially Equivalent |