FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES
K Number: K061646
·
Decision Jun 27, 2006
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
18
Applicant Total
60
Review Days
15
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Basic Information
- Device Name
- LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES
- K Number
- K061646
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Laserscope
- Date Received
- June 12, 2006
- Decision Date
- June 27, 2006
- Product Code
- FBO
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- Y
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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FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE
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KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO
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FDA Class 2
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ANCHORAGE SCOPE, MODEL 000003
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KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Laserscope
| K Number | Device Name | ||
|---|---|---|---|
| K062719 | GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES | Dec 1, 2006 | Substantially Equivalent |
| K034011 | GEMINI SURGICAL LASER SYSTEM & ACCESSORIES | Mar 30, 2004 | Substantially Equivalent |
| K024206 | AURA ISURGICAL LASER SYSTEM & ACCESSORIES | Nov 17, 2003 | Substantially Equivalent |
| K020021 | LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION) | Jul 2, 2002 | Substantially Equivalent |
| K010834 | LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES | May 21, 2001 | Substantially Equivalent |
| K010284 | LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) | May 1, 2001 | Substantially Equivalent |
| K003765 | LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) | Mar 6, 2001 | Substantially Equivalent |
| K003147 | LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION) | Dec 15, 2000 | Substantially Equivalent |
| K990718 | ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) | Mar 8, 2000 | Substantially Equivalent |
| K990903 | LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) | Aug 27, 1999 | Substantially Equivalent |