FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA
K Number: K964561
·
Decision Feb 11, 1997
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
1
Applicant Total
4
Review Days
90
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA
- K Number
- K964561
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4530
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioenterics Corp.
- Date Received
- November 13, 1996
- Decision Date
- February 11, 1997
- Product Code
- FDG
- 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 |
|---|---|---|---|
| FDG | Retractor, Fiberoptic | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FDG), ordered by most recent decision date.
View all