FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE
K Number: K870679
·
Decision Mar 30, 1987
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
18
Applicant Total
52
Review Days
39
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Basic Information
- Device Name
- VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE
- K Number
- K870679
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Van-Tec, Inc.
- Date Received
- February 19, 1987
- Decision Date
- March 30, 1987
- Product Code
- FBO
- 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 |
|---|---|---|---|
| FBO | Cystourethroscope | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FBO), ordered by most recent decision date.
KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)
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FDA Class 2
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KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)
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FDA Class 2
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FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE
FDA 510(k)
FDA Class 2
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KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ANCHORAGE SCOPE, MODEL 000003
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FDA Class 2
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KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Van-Tec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880098 | VAN-TEC AUTO BIOPSY NEEDLE | Mar 2, 1988 | Substantially Equivalent |
| K880096 | VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP | Mar 2, 1988 | Substantially Equivalent |
| K880095 | BERGER PROSTATE CULTURE CYTOLOGY BRUSH | Mar 2, 1988 | Substantially Equivalent |
| K880099 | VAN-TEC BLADDER EVACUATOR | Mar 2, 1988 | Substantially Equivalent |
| K880094 | VAN-TEC ENDOPYELOTOMY KNIFE | Feb 29, 1988 | Substantially Equivalent |
| K874112 | VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER | Feb 11, 1988 | Substantially Equivalent |
| K871777 | VAN-TEC REUSABLE HELICAL STONE BASKET | Jun 17, 1987 | Substantially Equivalent |
| K871779 | HELICAL STONE BASKET (DISPOSABLE) | Jun 17, 1987 | Substantially Equivalent |
| K870557 | VAN-TEC PUMPING SYSTEM | Mar 30, 1987 | Substantially Equivalent |
| K870696 | VAN-TEC SEGURA STONE BASKET W/PROTECTIVE SHEATH | Mar 30, 1987 | Substantially Equivalent |