FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOCAM
K Number: K963046
·
Decision Nov 1, 1996
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
1391
Applicant Total
33
Review Days
88
Basic Information
- Device Name
- ENDOCAM
- K Number
- K963046
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CORIN U.S.A.
- Date Received
- August 5, 1996
- Decision Date
- November 1, 1996
- 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 CORIN U.S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K130343 | CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS | May 28, 2013 | Substantially Equivalent |
| K130634 | CORIN METAFIX HIP STEM | May 24, 2013 | Substantially Equivalent |
| K121439 | METAFIX FEMORAL HIP STEM SIZE 1 | Sep 14, 2012 | Substantially Equivalent |
| K113060 | UNITY TOATAL KNEE SYSTEM | Sep 10, 2012 | Substantially Equivalent |
| K120362 | METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY | May 4, 2012 | Substantially Equivalent |
| K111481 | CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS | Feb 6, 2012 | Substantially Equivalent |
| K111911 | CORIN OPTIMOM MODULAR HEAD | Aug 4, 2011 | Substantially Equivalent |
| K103518 | TRINITY ACETABULAR SYSTEM | Mar 9, 2011 | Substantially Equivalent |
| K093472 | TRINITY ACETABULAR SYSTEM | Nov 23, 2010 | Substantially Equivalent |
| K083312 | MINIHIP STEM | Apr 5, 2010 | Substantially Equivalent |