DIRECTVIEW, LIGHTGUIDE, MODEL(S) 10RLL-320 LAPAROSCOPE, 10DLG-320 DISPOSABLE LIGHT GUIDE FOR ABOVE
FDA 510(k) clearance K072613 · decided 2008-04-21
Clearance details
- K-number
- K072613
- Device name
- DIRECTVIEW, LIGHTGUIDE, MODEL(S) 10RLL-320 LAPAROSCOPE, 10DLG-320 DISPOSABLE LIGHT GUIDE FOR ABOVE
- Applicant
- Micro Invasive Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-17
- Decision date
- 2008-04-21
- Days to decision
- 217 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Danielson, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.