FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYSTOSCOPE
K Number: K941992
·
Decision Nov 30, 1995
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
18
Applicant Total
28
Review Days
584
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Basic Information
- Device Name
- CYSTOSCOPE
- K Number
- K941992
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgical Technologies, Inc.
- Date Received
- April 25, 1994
- Decision Date
- November 30, 1995
- 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)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Surgical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942029 | ARTHROSCOPE | Nov 8, 1995 | Substantially Equivalent |
| K946136 | INFINITECH LIGHTED INFUSION CANNULA | Oct 2, 1995 | Substantially Equivalent |
| K952566 | OSCILFLATOR | Aug 31, 1995 | Substantially Equivalent |
| K951918 | SURGICAL TECHNOLOGIES, INC. SYRINGE | Jul 20, 1995 | Substantially Equivalent |
| K950683 | ARTHROGRAM TRAY | May 6, 1995 | Substantially Equivalent |
| K946135 | INFINITECH ASPIRATING LASER PROBE | Apr 18, 1995 | Substantially Equivalent |
| K946181 | INFINITECH SOFT TIP FLUTE NEEDLE | Mar 14, 1995 | Substantially Equivalent |
| K942030 | BIOPSY SCISSORS | Jun 27, 1994 | Substantially Equivalent |
| K942482 | PRESSURE MONITORING EXTENSION | Jun 14, 1994 | Substantially Equivalent |
| K941161 | FLEXIBLE GRASPING FORCEPS | May 4, 1994 | Substantially Equivalent |